Operative Neuromodulation Volume 1 Functional

Neuroprosthetic Surgery. An Introduction, 1st Edition

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Preface

Operative Neuromodulation is a rapidly evolving mul- we aim to facilitate a world-wide dissemination of author-
tidisciplinary biomedical and biotechnological field that itative information regarding this scientific and clinical
opens new options and possibilities not only for help- field, and to promote an expansion of current medical
ing patients but also for understanding the role of the practice and research into this area. Furthermore, we wish
nervous system in modulating all other bodily systems. to contribute towards a constructive integrative relation-
Many specialties are involved and multidisciplinary col- ship between the biomedical and technological fields
laboration is necessary for the further progress of the involved in neuromodulation. It is hoped that this book
field. The International Neuromodulation Society (INS) will have a positive impact in the continuously evolving
exists to promote, disseminate, and to be an advocate for research and practice of neuromodulation.
the science, education, best practice and accessibility
of all aspects of neuromodulation. The INS is directly Damianos E. Sakas, MD
associated with the International Functional Electrical Professor of Neurosurgery
Stimulation Society (IFESS) which aims to promote the Chairman, WFNS Neuromodulation Committee
research, application, and understanding of electrical stim-
ulation as it is utilized in the field of medicine. The Brian A. Simpson, MD, FRCS
World Federation of Neurosurgical Societies (WFNS) Consultant Neurosurgeon
has realised the potential of the field and recently created Ex-President, International Neuromodulation Society
a Neuromodulation Committee. Undoubtedly, many other
neuromodulation committees will be founded in other Elliot S. Krames, MD
specialties and all of them, in close collaboration with Editor in Chief, Neuromodulation
the INS, will advance neuromodulation. With this book, President, International Neuromodulation Society
Contents

An introduction
Sakas, D. E., Panourias, I. G., Simpson, B. A., Krames, E. S.:
An introduction to operative neuromodulation and functional neuroprosthetics,
the new frontiers of clinical neuroscience and biotechnology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3

Fodstad, H., Hariz, M.:

Electricity in the treatment of nervous system disease . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

Hatzis, A., Stranjalis, G., Megapanos, C., Sdrolias, P. G., Panourias, I. G., Sakas, D. E.:
The current range of neuromodulatory devices and related technologies . . . . . . . . . . . . . . . . . . . . . . . . . . 21

Pain
Raslan, A. M., McCartney, S., Burchiel, K. J.:
Management of chronic severe pain: spinal neuromodulatory and neuroablative approaches . . . . . . . . . . . . 33
Koulousakis, A., Kuchta, J., Bayarassou, A., Sturm, V.:
Intrathecal opioids for intractable pain syndromes. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43
Rainov, N. G., Heidecke, V.:
Management of chronic back and leg pain by intrathecal drug delivery. . . . . . . . . . . . . . . . . . . . . . . . . . . 49
Lind, G., Schechtmann, G., Winter, J., Linderoth, B.:
Drug-enhanced spinal stimulation for pain: a new strategy. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57
Kuchta, J., Koulousakis, A., Sturm, V.:
Neurosurgical pain therapy with epidural spinal cord stimulation (SCS) . . . . . . . . . . . . . . . . . . . . . . . . . . 65

Nicholson, C. L., Korfias, S., Jenkins, A.:

Spinal cord stimulation for failed back surgery syndrome and other disorders . . . . . . . . . . . . . . . . . . . . . . 71

Lanner, G., Spendel, M. C.:

Spinal cord stimulation for the treatment of chronic non-malignant pain . . . . . . . . . . . . . . . . . . . . . . . . . . 79

Rainov, N. G., Demmel, W., Heidecke, V.:

Dual electrode spinal cord stimulation in chronic leg and back pain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85

Kumar, K., Wilson, J. R.:

Factors affecting spinal cord stimulation outcome in chronic benign pain
with suggestions to improve success rate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
Rainov, N. G., Heidecke, V.:
Hardware failures in spinal cord stimulation (SCS) for chronic benign pain of spinal origin . . . . . . . . . . . . 101
VIII Contents

Beems, T., van Dongen, R. T. M.:

Minimally invasive placement of epidural plate electrodes under local anaesthesia
in spinal cord stimulation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
Vangeneugden, J.:
Implantation of surgical electrodes for spinal cord stimulation: classical midline laminotomy
technique versus minimal invasive unilateral technique combined with spinal anaesthesia . . . . . . . . . . . . . . 111
Slavin, K. V.:
Peripheral nerve stimulation for the treatment of neuropathic craniofacial pain . . . . . . . . . . . . . . . . . . . . . 115
Rogers, L. L., Swidan, S.:
Stimulation of the occipital nerve for the treatment of migraine: current state and future prospects . . . . . . . 121
Weiner, R. L.:
Occipital neurostimulation for treatment of intractable headache syndromes . . . . . . . . . . . . . . . . . . . . . . . 129

Spasticity and related disorders

Petropoulou, K. B., Panourias, I. G., Rapidi, C.-A., Sakas, D. E.:
The phenomenon of spasticity: a pathophysiological and clinical introduction
to neuromodulation therapies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137
Panourias, I. G., Themistocleous, M., Sakas, D. E.:
Intrathecal baclofen in current neuromodulatory practice: established indications
and emerging applications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145
Ethans, K.:
Intrathecal baclofen therapy: indications, pharmacology, surgical implant, and efficacy . . . . . . . . . . . . . . . . 155
Dykstra, D., Stuckey, M., DesLauriers, L., Chappuis, D., Krach, L.:
Intrathecal baclofen in the treatment of spasticity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 163
Marra, G. A., D’Aleo, G., Di Bella, P., Bramanti, P.:
Intrathecal baclofen therapy in patients with severe spasticity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173
Koulousakis, A., Kuchta, J.:
Intrathecal antispastic drug application with implantable pumps: results of a 10 year follow-up study. . . . . . 181
Dones, I.:
Intrathecal baclofen for the treatment of spasticity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185
Dario, A., Tomei, G.:
Management of spasticity in multiple sclerosis by intrathecal baclofen . . . . . . . . . . . . . . . . . . . . . . . . . . . 189
Sgouros, S.:
Surgical management of spasticity of cerebral origin in children . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193
Rietman, J. S., Geertzen, J. H. B.:
Efficacy of intrathecal baclofen delivery in the management of severe spasticity
in upper motor neuron syndrome . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 205
Richard, I., Menei, P.:
Intrathecal baclofen in the treatment of spasticity, dystonia and vegetative disorders. . . . . . . . . . . . . . . . . . 213
Francisco, G. E.:
Intrathecal baclofen in the management of post-stroke hypertonia:
current applications and future directions. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 219
Contents IX

Taira, T., Hori, T.:

Intrathecal baclofen in the treatment of post-stroke central pain, dystonia,
and persistent vegetative state. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 227
Stokic, D. S., Yablon, S. A.:
Neurophysiological basis and clinical applications of the H-reflex as an adjunct
for evaluating response to intrathecal baclofen for spasticity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 231
Petropoulou, K. B., Panourias, I. G., Rapidi, C.-A., Sakas, D. E.:
The importance of neurorehabilitation to the outcome of neuromodulation in spasticity . . . . . . . . . . . . . . . 243

Cardiovascular, cerebrovascular and respiratory disorders

Vincenzo, S., Kyventidis, T.:
Epidural spinal cord stimulation in lower limb ischemia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 253
Claeys, L. G. Y., Berg, W., Jonas, S.:
Spinal cord stimulation in the treatment of chronic critical limb ischemia . . . . . . . . . . . . . . . . . . . . . . . . . 259
Upadhyaya, C. D., Sagher, O.:
Cervical spinal cord stimulation in cerebral ischemia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 267
Robaina, F., Clavo, B.:
Spinal cord stimulation in the treatment of post-stroke patients: current state and future directions. . . . . . . . 277
Ansari, S., Chaudhri, K., Moutaery, K.:
Neurostimulation for refractory angina pectoris . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 283
Taira, T., Hori, T.:
Diaphragm pacing with a spinal cord stimulator: current state and future directions . . . . . . . . . . . . . . . . . . 289
Tyler, D. J.:
Neuroprostheses for management of dysphagia resulting from cerebrovascular disorders . . . . . . . . . . . . . . . 293

Bladder, bowel, and sexual disorders

Rapidi, C.-A., Panourias, I. G., Petropoulou, K., Sakas, D. E.:
Management and rehabilitation of neuropathic bladder in patients with spinal cord lesion . . . . . . . . . . . . . . 307
Vignes, J. R., de Seze, M., Guerin, J., Barat, M.:
Sacral neuromodulation as a functional treatment of bladder overactivity . . . . . . . . . . . . . . . . . . . . . . . . . 315
Vignes, J. R., Bauchet, L., Ohanna, F.:
Dorsal rhizotomy combined with anterior sacral root stimulation for neurogenic bladder. . . . . . . . . . . . . . . 323
Kutzenberger, J.:
Surgical therapy of neurogenic detrusor overactivity (hyperreflexia) in paraplegic patients
by sacral deafferentation and implant driven micturition by sacral anterior root stimulation:
methods, indications, results, complications, and future prospects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 333
Ratto, C., Parello, A., Donisi, L., Doglietto, G. B.:
Sacral neuromodulation in the treatment of defecation disorders. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 341
Matzel, K. E.:
Sacral nerve stimulation for fecal disorders: evolution, current status, and future directions . . . . . . . . . . . . . 351

Meloy, S.:
Neurally augmented sexual function . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 359
X Contents

Kothari, S.:
Neuromodulatory approaches to chronic pelvic pain and coccygodynia . . . . . . . . . . . . . . . . . . . . . . . . . . . 365

Functional electrical stimulation

Ring, H., Weingarden, H.:
Neuromodulation by functional electrical stimulation (FES) of limb paralysis after stroke . . . . . . . . . . . . . . 375
Wang, R.-Y.:
Neuromodulation of effects of upper limb motor function and shoulder range of motion
by functional electric stimulation (FES). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 381
Popović, D. B., Sinkj
r, T.:
Neuromodulation of lower limb monoparesis: functional electrical therapy of walking . . . . . . . . . . . . . . . . 387
Newham, D. J., Donaldson, N. de N.:
FES cycling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 395
Morita, I., Keith, M. W., Kanno, T.:
Reconstruction of upper limb motor function using functional electrical stimulation (FES) . . . . . . . . . . . . . 403

Neuroprostheses
Stieglitz, T.:
Neural prostheses in clinical practice: biomedical microsystems in neurological rehabilitation . . . . . . . . . . . 411
Rupp, R., Gerner, H. J.:
Neuroprosthetics of the upper extremity – clinical application in spinal cord injury
and challenges for the future . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 419
Koch, K. P.:
Neural prostheses and biomedical microsystems in neurological rehabilitation . . . . . . . . . . . . . . . . . . . . . . 427
Stieglitz, T.:
Restoration of neurological functions by neuroprosthetic technologies: future prospects
and trends towards micro-, nano-, and biohybrid systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 435

Emerging applications
Robaina, F., Clavo, B.:
The role of spinal cord stimulation in the management of patients with brain tumors . . . . . . . . . . . . . . . . . 445
Morita, I., Keith, M. W., Kanno, T.:
Dorsal column stimulation for persistent vegetative state . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 455
Dario, A., Pisani, R., Sangiorgi, S., Pessina, F., Tomei, G.:
Relationship between intrathecal baclofen and the central nervous system . . . . . . . . . . . . . . . . . . . . . . . . . 461
Riener, R.:
Robot-aided rehabilitation of neural function in the upper extremities . . . . . . . . . . . . . . . . . . . . . . . . . . . . 465
Rainov, N. G., Heidecke, V.:
Experimental therapies for chronic pain. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 473
Author index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 479
Index of keywords . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 481

Listed in Current Contents

An introduction
Acta Neurochir Suppl (2007) 97(1): 3–10
# Springer-Verlag 2007
Printed in Austria

An introduction to operative neuromodulation and functional

neuroprosthetics, the new frontiers of clinical neuroscience and biotechnology

D. E. Sakas1 , I. G. Panourias1 , B. A. Simpson2 , and E. S. Krames3

1
P. S. Kokkalis Hellenic Center for Neurosurgical Research, Athens, Greece
2
Department of Neurosurgery, University Hospital of Wales, Heath Park, Cardiff, UK
3
Pacific Pain Treatment Center, San Francisco, CA, USA

Summary networks excite, inhibit or tune adjacent or remote neu-

Operative neuromodulation is the field of altering electrically or chem- rons or neural networks in order the latter to deliver re-
ically the signal transmission in the nervous system by implanted devices sponses, which are better adapted to the demands of the
in order to excite, inhibit or tune the activities of neurons or neural net- environment of an organism and more suitable for en-
works and produce therapeutic effects. It is a rapidly evolving biomedical
and high-technology field on the cutting-edge of developments across a
suring its successful survival. In the biotechnological
wide range of scientific disciplines. The authors review relevant literature context, neuromodulation is a field of science, medi-
on the neuromodulation procedures that are performed in the spinal cord cine, and bioengineering that encompasses implantable
or peripheral nerves in order to treat a considerable number of conditions
and non-implantable technologies, electrical or chemical
such as a) chronic pain (craniofacial, somatic, pelvic, limb, or due to failed
back surgery), b) spasticity (due to spinal trauma, multiple sclerosis, upper with the aim to improve the quality of life for humans
motor neuron disease, dystonia, cerebral palsy, cerebrovascular disease suffering from neurological disorders. In the clinical con-
or head trauma), c) respiratory disorders, d) cardiovascular ischemia, e) text, several definitions have been proposed and the most
neuropathic bladder, and f) bowel dysfunction of neural cause. Functional
neuroprosthetics, a field of operative neuromodulation, encompasses the widely accepted are described below. Neuromodulation
design, construction and implantation of artificial devices capable of gen- can be defined as:
erating electrical stimuli, thereby, replacing the function of damaged parts
of the nervous system. The present article also reviews important lit- a) the science of how electrical, chemical, and mechan-
erature on functional neuroprostheses, functional electrical stimulation ical interventions can modulate or change central and
(FES), and various emerging applications based on microsystems devices,
peripheral nervous system functioning,
neural engineering, neuroaugmentation, neurostimulation, and assistive
technologies. The authors highlight promising lines of research such as b) a form of therapy in which neurophysiological sig-
endoneural prostheses for peripheral nerve stimulation, closed-loop sys- nals are initiated or influenced with the intention of
tems for responsive neurostimulation or implanted microwires for micro- achieving therapeutic effects by altering the function
stimulation of the spinal cord to enable movements of paralyzed limbs.
The above growing scientific fields, in combination with biological re- and performance of the nervous system, and=or
generative methods, are certainly going to enhance the practice of neuro- c) the therapeutic alteration of activity in the central,
modulation. The range of neuromodulatory procedures in the spine and peripheral or autonomic nervous systems, electrically
peripheral nerves and the dynamics of the biomedical and technological
domains which are reviewed in this article indicate that new breakthroughs
or pharmacologically, by means of implanted or non-
are likely to improve substantially the quality of life of patients who are implanted devices.
severely disabled by neurological disorders.
More recently, it has been proposed that neuromod-
Keywords: Operative neuromodulation; functional neuroprosthetic sur-
gery; neuroprostheses; chronic pain; spasticity; cardiovascular ischemia;
ulation is the reversible use of electrical stimulation
functional electrical stimulation; neuropathic bladder; neuropathic bowel. or centrally-delivered pharmaceutical agents to manip-
ulate nervous system activity in order to treat specific
types of chronic pain, spasticity, epilepsy, ischemia,
Definitions
cardiac, bowel, bladder dysfunction, nervous system
In biology, neuromodulation can be defined as the injury, and movement, visual, auditory or psychiatric
process by which chemical substances, neurons or neural disorders [3].
4 D. E. Sakas et al.

All the above definitions imply that neuromodulation implanted electrodes in order to achieve functional acti-
requires the use of implanted technology or device in the vation or inhibition of specific neuronal groups, path-
body of a patient to achieve a therapeutic goal. Much of ways or networks. A fascinating review of the history
neuromodulation, exclusive of external devices such as and potential applications of electricity in the nervous
transcutaneous neural stimulation (TNS) or transcranial system is provided in this volume by Fodstad and Hariz.
magnetic stimulation (TMS), has an interventional or Functional electrical stimulation (FES) is the selective
operational character. In most clinical or therapeutic set- stimulation of motor fibers in order to produce func-
tings, therefore, it is useful to us to further modify the tional muscle contractions by approaching that fibers
character of neuromodulation by adding the modifier closely either transcutaneously (non-invasively), subcu-
‘‘operative,’’ distinguishing it from less invasive neu- taneously (invasively) or by putting an electrode in close
romodulatory techniques such as TMS. We call this proximity to a Ranvier’s node within the nerve. FES is
therapy, ‘‘Operative Neuromodulation.’’ We propose electrical stimulation of a muscle deprived of normal
that Operative Neuromodulation is defined as an inter- control in order to produce a functionally useful contrac-
ventional field of medicine that alters neuronal signal tion. The electrical stimulation that produces only a sen-
transmissions by implanted devices, either electrically sory response cannot be termed as FES and the electrical
or chemically, in order to excite, inhibit or tune the stimulation that aims only to reduce pain is also not FES.
activities of neurons or neural networks to produce ther- Assistive technologies are items, pieces of equipment,
apeutic effects. This definition is neither the best possi- devices or product systems, whether acquired commer-
ble nor the final one to be formulated. Undoubtedly, in cially or customised that are used to increase, maintain
years to come, better definitions will be proposed. The or improve functional capabilities of individuals with
difficulty in defining neuromodulation may, in part, disabilities. Assistive technologies encompass products
reflect the fact that this is a subject with at least two such as wheelchairs, walkers, ramps, communication
key areas of complexity. Firstly, neuromodulation is a boards etc. For a review see chapter by Sakas and col-
rapidly evolving multidisciplinary biomedical and tech- leagues. Neuroprosthetics is a biotechnological field
nical field and, secondly, the procedures are performed dedicated to the study, design, construction and implan-
on the nervous system, but affect any organ or system of tation of artificial devices that generate electrical stimuli
the human body. Currently, the clinical specialists who by initiating action potentials in nerve fibers in order to
are involved in neuromodulation come from anesthesiol- replace the function of damaged parts of the nervous
ogy, neurosurgery, neurology, neurophysiology, cardiol- system. Neural engineering applies methods and princi-
ogy, and orthopedics, but because of the systemic effects ples of engineering, physical and mathematical science
and benefits of this therapy, this relatively new discipline to investigate the nervous system and construct technol-
of medicine will, most likely, encompass or influence ogical devices that interface with it. An alternative defi-
most medical specialties. nition is that neural engineering is the science that aims
The term neuromodulation refers to the use of tech- to interface electronics to brain, spinal cord, and nerves
nology at the neural interface and is a generic term that, by combining the potentials of microsystems technology
today, should supercede many specific terms used in the and microelectronics with the current understanding of
past including neuroaugmentation, neurostimulation, the electrochemical, neuroanatomical and neurophysiol-
neural prosthetics, functional electrical stimulation, as- ogical properties and constraints of the nervous system.
sistive technologies, and neural engineering. Because As we see, neuromodulation, defined as the interface of
these terms are still within our clinical and scientific technology with the nervous system to produce benefit
lexicon, it is worthwhile to define them here although to the patient, encompasses all of the varied specific
they will be further discussed and refined within the terms above. Neuromodulation, though diverse and en-
chapters of this volume. Neuroaugmentation, a term often compassing multiple specialties, is specific to the use of
used synonymously with neuromodulation, is the en- technology in impacting positively on the body. It is the
hancement of the nervous system and its activity by fastest growing field of medicine today.
implantable devices that convey either electrical stimu-
lation, delivery of drugs or chemicals, or implantation of
cells in order to produce therapeutic effects. Neuro- Sections of current volume
stimulation is the processes and technologies of applying
The present compilation of articles in this volume,
electrical currents of varying parameters by means of
titled Operative Neuromodulation, and subtitled An
An introduction to operative neuromodulation and functional neuroprosthetics 5

Introduction to Functional Neuroprosthetic Surgery de- ical and emotional functioning of the individual. To
scribes techniques whereby engineered technology is meet these goals, pain practitioners should be able to
applied to the spinal cord or peripheral nerves, either use all of the ‘‘tools of the trade’’ or, if unable to use
by contact with non-neural coverings (e.g. dura mater), them, to refer the patients to the specialists who know
or directly within the fluid media that surrounds the how to appropriately use these tools [1]. Spinal cord
nervous system (e.g. cerebrospinal fluid) in order to in- stimulation (SCS) has been acknowledged as an appro-
fluence nervous system function and produce therapeutic priate and effective therapy for chronic non-malignant
benefit. These techniques are invasive and representative pain. The first section of the Volume is dedicated on
examples include epidural stimulation for pain or in- neuromodulation for pain and starts with a comparative
trathecal drug delivery systems for spasticity or pain. review of ablative versus modulatory spinal procedures
In addition, this volume includes a section on Functional (Burchiel). Spinal cord stimulation (SCS) has been
Electrical Stimulation (FES) techniques which can be acknowledged as a treatment for chronic non-malignant
termed as non-invasive Functional Neuroprosthetic Sys- pain. Patient selection criteria, surgical procedure, post-
tems because they are applied by transcutaneous contact operative complications, and clinical outcome follow-
with the nervous system, rather than being implanted. ing SCS are described by some of the most experienced
Neuromodulation lies at the intersection of biomed- practitioners of SCS (Kumar, Rainov, Kuhta, Lanner).
ical and techonological progress and can function as Surgical considerations for improving implantation tech-
a broad area for convergence, exchange and cross-fertil- nique and minimising hardware-related failures are dis-
ization of ideas. The aim of the editors is to present a cussed by Beems, Jenkins, Vangeneugden, and Rainov.
comprehensive and authoritative review on this field. The role of peripheral nerve stimulation (PNS) in the
The authors of this volume have been selected because management of intractable migraine and craniofacial
of their contributions or innovative works performed painful syndromes is underlined in separate articles by
over the years and presented at major international meet- Slavin, Weiner, and Rogers. Finally, the chronic intrathe-
ings. The included articles within this volume describe cal infusion of analgesic drugs either as single therapy
what is known about neuromodulation today and span or, more interestingly, in combination with SCS in the
from the state-of-the-art knowledge base of established management of intractable back and leg pain are also
neuromodulation procedures used at the spinal cord and= presented (Rainov, Koulousakis, Linderoth).
or peripheral nerves for pain and spasticity, bladder and Chronic intrathecal baclofen (ITB) administration
bowel dysfunction, and cardiovascular disease to what through an implanted pump has become an established
is known about forefront and more current applications, therapy for severe, intractable spasticity of spinal or
utilizing biohybrid materials. The volume concludes cerebral origin. Pathophysiological mechanisms, guide-
with neuroprostheses and relevant emerging applica- lines for selecting appropriate candidates, surgical tech-
tions. The authors were asked to place emphasis on both nique, procedure- and device-related complications, and
the understanding of the neuronal networks involved functional outcome following ITB therapy in adult and
and on practical clinical matters such as criteria and pediatric populations are presented in detail by Dykstra,
guidelines for selecting suitable patients for neuromod- Ethans, Koulousakis, Rietman, Richard, Sakas, and
ulation, descriptions of interventional or surgical tech- Sgouros. The clinical interrelationships and the outcome
nique, the organization of effective multidisciplinary of ITB depending on the underlying pathology such
teams, how to deal with borderline cases, and how to as upper motor neuron syndrome (Rietman), multiple
evaluate clinical outcome. Special emphasis has been sclerosis (Dario), dystonia (Richard), cerebral palsy
given to the understanding of why some do well, while (Sgouros), cerebrovascular disease (Francisco) or injury
others do not. Moreover, each chapter gives suggestions (Petropoulou) are presented in detail in this volume.
for clinical improvements and discusses the personal Intrathecal baclofen’s effects on functional capacity of
views of the authors on new directions and opportunities patients such as ambulatory ability, ease of caregiving,
for the future. and self-dependency are discussed by Dones and Marra.
Undeniably, the management of chronic pain has been The potential role of chronic ITB therapy in the man-
the greatest success story in the field of neuromodulation agement of dystonia, in alleviating chronic pain, and
and much has been written about this indication. The in recovery from persistent vegetative state are also
recognized goals of pain treatment are reduction in the presented (Richard, Taira). The significance of special
intensity of a patient’s pain while improving both phys- neurophysiological tests in the overall management of
6 D. E. Sakas et al.

spasticity is highlighted by Stokic. The role of neu- their respective articles, Kanno, Ring and Wang and
rorehabilitation after the initiation of ITB therapy, the colleagues present the neural pathophysiology of this
significance of close collaboration between involved dis- disorder, its epidemiological background, the clinical
ciplines, and the future prospects of the field are dis- indications for the use of FES, selection criteria of
cussed in the chapters by Petropoulou and Panourias. patients receiving FES, and the methodology of FES,
SCS, as effective therapy for refractory lower limb particularly for the restoration of function to a paretic
ischemia, is discussed in the chapters by Sciacca and or paralyzed upper limb and shoulder, respectively.
Clayes, while SCS for angina pectoris and cerebral ische- Sinkjaer et al. outline the mechanisms for the action of
mia is discussed in separate articles by Moutaery, Sagher, FES and its role in improving stance and walking abil-
and Robaina, respectively. A compelling argument in ity in patients suffering from lower limb monoparesis.
favor of early use of electrical stimulation in these con- Donaldson and Newham present, in detail, FES cycling
ditions would arise if it favorably modified the course of and discuss its future as a method for strengthening
the underlying condition. It is also encouraging that, in paraplegic muscles and supporting walking capacity in
the relevant literature, there is some evidence of a pos- patients. Any surface stimulation system, however, has
sible ‘‘limb salvage’’ effect of SCS in a subgroup of inherent limiting factors including difficulty in repeat-
patients with critical limb ischemia and a possible cardi- edly locating correct points for stimulation, difficulty in
oprotective effect of SCS in cardiac ischemia [8]. reaching deeper lying nerves, lack of selectivity, varia-
Other uses for electrical stimulation are discussed in tion in skin impedance, necessity for resetting pulse-
several different chapters. Indications for electrical stim- amplitude because of changes in electrode position,
ulation such as dysphagia and diaphragm paralysis are discomfort to the patient, and low efficiency of the en-
discussed by Taira and Tyler and the future directions of ergy used for activation of the nerve. To actualize the
the field are summarized. Neuropathic bladder and as- great potential of FES we need answers and effective
sociated detrusor dysfunction are disabling conditions solutions to the above problems.
that occur commonly following severe spinal cord injury.
Some of the most well-known investigators (Barat,
Bauchet, Kutzenberger, Rapidi) describe their research Neuroprostheses and emerging applications
and clinical experience with neuromodulatory therapies
Electronic sophisticated and high technological de-
for these urologic disorders and discuss, in detail, the
vices that translate the intention to move paralyzed limbs
anatomic and physiologic foundations, the selection cri-
into actual movement offer a broad area for research in
teria for the use of neuromodulation, the surgical tech-
the laboratory and clinic and represent a great hope for
niques involved, the complications that may arise, the
severely disabled sufferers. Morita, Keith and Kanno
functional outcomes derived, and the future prospects
describe, in our estimation, one of the most successful
for the field. The current state and the future directions
neuroprostheses, so far, for patients with tetraplegia or
for the neuromodulatory management of fecal inconti-
arm monoplegia, which converts minimal shoulder move-
nence, a severely disabling condition following SCI,
ments into the basic movements of the contralateral arm
through sacral nerve root stimulation, is discussed by
and hand. Stieglitz describes the development and appli-
Ratto and Matzel. The potential role of neuromodulatory
cation of micro-, nano-, and biohybrid systems in neu-
interventions in modulating sexual dysfunction is dis-
rorehabilitation and analyzes their bioethical and social
cussed by Meloy. Kothari discusses the mechanisms of
implications. Koch provides an elaborate description of
chronic neuropathic pain of pelvic origin and further dis-
tiny electrodes, microelectronics or connectors which are
cusses the role for peripheral nerve stimulation (PNS) in
currently used to interface human nervous system and
its management.
highlights critical elements that should be improved in
their design. The direct brain control of FES systems
constitutes a great challenge for neuroscientists; Rupp
Functional electrical stimulation (FES)
and Ruddiger discuss how biomedical microsystems
Functional Electrical Stimulation (FES) holds con- might be implemented with a special emphasis in their
siderable promise for improving and enhancing motor application for restoring grasping capacity after severe
capacity in patients suffering from severe limb paresis cervical cord injury.
or paralysis, either secondary to stroke, head injury, or The last section in this volume includes articles on
neural trauma from intervertebral disc herniation. In emerging applications. The role of SCS as an adjunctive
An introduction to operative neuromodulation and functional neuroprosthetics 7

treatment to radio- and chemotherapy of high grade glio- pain exists untreated for long periods of time [8]. The
mas (Robaina) and the efficacy of SCS in enhancing success of any neuromodulation intervention, therefore,
recovery from a persistent vegetative state (Morita) are depends on practitioners finding optimal therapies that
discussed in this section. Riener provides us with an work in terms of timing and means for each patient.
overview of existing systems that support deficits in It is important that the number of patients, for whom
movement of the upper limbs that occur after disabling each neuromodulation therapy is appropriate, is rela-
neurological pathologies; each device is compared to tively small when compared to the total number of pa-
others with respect to technical function, applicability, tients suffering from any one disease. The editors and
and clinical outcomes. Finally, the future prospects of authors of this volume believe that potential candidates
biological treatments for pain and of baclofen use in for treatment should be referred only to neuromod-
various neurological disorders are discussed by Rainov ulation specialists, in established, experienced centers
and Dario, respectively. because: a) patients should be carefully screened, eval-
uated diagnosed and selected for treatment by a multi-
disciplinary team, b) all the facilities, equipment, and
Socioeconomic aspects of neuromodulation professional personnel required for the proper diagnosis,
treatment, training, support, and follow-up of the patient
Great strides have been made in the development,
should be available, and c) patients with implantable
application, and commercialisation of neuromodulation,
devices must have appropriate follow-up, receive ade-
FES, and neural prostheses over the last 20 years. Sen-
quate training in the device use, care and overall support.
sory and motor neuromodulation systems have gained
In addition to the above, the practice of neuromodulation
FDA approval and European CE marks and widespread
within established centers will provide reliable, mean-
acceptance in clinical practice. It is widely accepted
ingful, high-level evidence that is essential not only to
that neuromodulation therapies may substantially reduce
improve future case selection but also to persuade com-
costs for less invasive therapies including, but not lim-
missioners, insurance companies, and others to pay for
ited to, medications, cognitive behavioural therapies,
the treatment. Poor case selection not only wastes re-
and physical therapies. Cost-benefit analyses that prove
sources (including hospital beds, surgical time, etc.) but
the efficacy and financial gains to health systems from
also subjects the patients to unnecessary surgery with all
neuromodulatory procedures are increasingly reported
its attendant risks and disappointments [7]. Undoubt-
[7]. As an example of cost savings of neuromodulation
edly, the future practice of neuromodulation will be
therapy, intrathecal baclofen has been shown to be cost
affected by technological advances made in the field
effective because it improves patient’s quality of life and
and by changing trends in practice, moving away from
reduces the cost of treatment for complications of severe
external therapeutic systems towards internal therapeutic
spasticity and hospitalizations. However, and unfortu-
systems and moving towards out-patient neuromod-
nately, in spite of these obvious cost savings, there still
ulation care. Furthermore, it is expected that there will
exists a ‘‘value-for-money’’ debate within many payor or
be an increased demand for more cost-effective thera-
medical insurance organizations who are asking whether
pies for the less severely handicaped with less severe
it is even worthwhile to perform neuromodulation, at all.
afflictions.
In spite of this debate, it is a generally accepted prin-
In order to help patients, worldwide, we should iden-
ciple that appropriate, neuromodulation therapies should
tify the major challenges that should be overcome and
not be used at early stages of illness before trialing more
address many important issues such as: conducting
conservative and less costly therapies such as pharma-
studies that will provide high-quality data on outcome,
cological, functional restorative or behavioural thera-
obtaining necessary government approvals for new
pies. However, as we learn more about the clinical and
products or applications, maintaining compliance with
cost effectiveness of neuromodulatory therapies, we can
FDA or European CE product and manufacturing re-
begin to make a good case for offering neuromodula-
quirements, minimizing reliance on sole suppliers or key
tion therapies at earlier stages of treatment for many dis-
distributors and addressing product liability. All these
ease processes. Some, in fact, do argue that it may not be
practitioners who have expertise in the field, must re-
justified to delay neuromodulation therapies for any
flect on and need to work on the formation of guidelines
extended period of time because there do exist substan-
for patients, doctors and industry regarding the proper
tial risks of physical, psychological and social damage
application of neuromodulation therapies. Furthermore,
due to either ischemia or neuropathic pain, when that
8 D. E. Sakas et al.

the obvious ethical questions that arise from too close future of neuromodulation, it is important to make great
collaboration of health care professionals with the in- leaps forward in functionality, acceptance and profitabil-
dustry that produce neuromodulation devices must be ity of neuromodulatory devices and neuroprostheses.
answered by all of us, industry and the clinic, alike. Such progress will require the input and support of sci-
We need to establish ethical standards of practice that entists, industry, government, and education and re-
guide clinician relationships with industy in a well- search organizations.
defined framework. Undeniably, the great challenge is to gain a better
Finally, because patients are being denied the benefit understanding of how neuromodulation exerts its di-
of neuromodulatory procedures because of lack of in- verse beneficial effects, an issue of mechanisms. Reach-
formation or mistaken medical or cost considerations, ing a deeper understanding of the mechanisms operant
expert opinion regarding neuromodulation should be when using these techniques will depend on progress in
widely published and disseminated across the world. The biophysics, neural networks and neural transmission
International Neuromodulation Society (INS) exists ‘‘to research, computational biology, and particularly, com-
promote, disseminate, and advocate for the science, edu- putational neuromodulation [5]. Also, the enhancement
cation, best practice and accessibility of all aspects of of our capacity to intervene beneficially on dysfunc-
neuromodulation’’. Importantly, because the disease that tional neural systems and help patients depends on prog-
we treat and the science of neuromodulation does not ress in many new technological fields including neural
belong to any one ‘‘study group’’, the INS is founded as engineering microsystems technologies, microelectron-
a multidisciplinary society to be inclusive of all scien- ics, nanotechnologies, biomimetics etc. Such progress
tists, physicians, bioengineers, members of the industry, is likely to create new opportunities and new fields of
and other professionals who have a primary interest clinical practice and research. With respect to neuro-
in the field of neuromodulation [1]. The INS is directly surgery, in particular, Operative Neuromodulation does
associated with the International Functional Electrical signify a transition of emphasis from the conventional
Stimulation Society (IFESS) which aims to promote the resection of masses and surgical ablative procedures to
research, application, and understanding of electrical a ‘‘new surgery’’ of neural re-engineering of deranged
stimulation as it is utilized in the field of medicine. In function.
1999, the INS and IFESS became sister societies. The
importance of this field has also recently been reognized
by the World Federation of Neurosurgical Societies Conventional approaches
(WFNS), which decided that a special Committee on
Neuromodulation as a field will be enhanced by the
Neuromodulation should be formed. This Committee,
expansion of our list of indications for therapeutic pro-
in collaboration with the INS, has the aim of disseminat-
cedures. One such example is the currently explored role
ing appropriate peer reviewed information that promotes
of PNS in chronic neuropathic pain, cluster headache,
expert application of neuromodulation treatments across
and trigeminal neuralgia. However, the practice of neu-
the world.
romodulation will not grow if our literature continues to
rely on published anecdotal material biased by the self-
serving evaluations of implanters and will only improve
Future directions
if we base it on the results and conclusions of large
The field of neuromodulation is diverse and high- randomized controlled trials with sufficiently long fol-
ly technical. Neuromodulation, as we define it by this low-up, after implantation. In these studies, patients who
volume, is not only and merely a devices-based field, have similarities in clinical profiles and implantation
but a field that encompasses many diverse disciplines times should be compared by independent observers
including neurophysiology, neuroanatomy, neural net- using consistent, valid and reliable measures. Moreover,
works, computational analysis, bioengineering, met- there should be multiple assessments of outcomes in-
allurgy, chemistry, electrical engineering, psychology, cluding, but not limited to, pain, but also physical func-
and applied clinical practice. Operative Neuromodula- tioning, medication use, work status, health care use,
tion, as we defined above, is the science of implanta- and the impact of the technology on the quality of life
tion of these diversely conceived and manufactured of patients. In addition, the neuromodulation practice
devices. It is the cutting-edge of development across a may improve by the use of computer modelling to pre-
wide range of scientific disciplines. In order to enrich the dict successful response to neurostimulation and to cus-
An introduction to operative neuromodulation and functional neuroprosthetics 9

tomize the electrodes’ position and programming para- plex and intelligent systems. Consumer opinions and
meters for each individual patient. frustrations regarding the features and functions of
current neuroprostheses should be taken seriously into
Neurotechnological developments account in order to design better systems. To satisfy
such demands, future developments should aim to-
There are many areas where important developments
wards miniaturization and extreme integration of in-
may take place in the years to come. Functional restora-
formation-technology and information exchange between
tion may well involve combined application of what
the neuromodulation system and the patient’s body and
have been considered separate approaches and include:
development of modular systems that can be adapted,
– Endoneural prostheses for peripheral nerve stimula- altered and adjusted to the patient’s specific needs with
tion (PNS); this important line of research has shown relative ease.
that motor fibers stimulation can be more effective if
the electrode is placed in close proximity to the node
Neuroprotective stimulation and integration
of Ranvier.
with biological therapies
– Closed loop systems for neuromodulation; these sys-
tems represent an important development and aim to A close collaboration between all involved disciplines
be capable of ‘‘responsive neurostimulation’’ that is and patients who need and use these devices is of great
not applied on fixed schedules, but is triggered by importance for the development of new neuromodula-
central nervous system activity. tion therapies. Immense therapeutic potential may arise
– Hybrid neural interfaces; these devices are a very from the convergence of efforts and close collaboration
exciting area of development and are constructed with of patients, biomedical scientists, biotechnological engi-
the aim to establish connections for communication neers and manufacturers. An area that has not attracted
with regenerating neurons. sufficient interest and deserves to be investigated, in the
– Spinal cord interfaces; developments in this area rep- years to come, is the neuroprotective effects of neural
resent a great promise for many unfortunate human stimulation. This is a field of great promise because, in
beings who have suffered serious spinal cord damage. the future, electrical stimulation will be based on ad-
– Intraspinal microstimulation via implanted microwires; vances in neural engineering such as micro-electrode
this most exciting work concerns the utility of such arrays [6] and will certainly be much more refined, pre-
products to enable functional movements of limbs in cise and therapeutically effective. The potential of all
experimental animals after spinal cord injury. It is available modalities should be exploited. Particularly,
encouraging that coordinated intraspinal microstimula- we must answer how electrical stimulation and biologi-
tion of motor neuron cell bodies in the ventral horn cal mechanisms of neural repair could work together in
produced fatigue-resistant stepping movements [4]. order to maximize the recovery of function after CNS
damage. One can envisage the use of electrical stimula-
One of the most exciting approaches in rehabilita-
tion not only to alter signalling but to fill neural trans-
tion of locomotion after spinal cord injury may involve
mission gaps, to direct growth of axons, and to exert
a hybrid neural prosthesis consisting of a mechanical
protective effects. Hence, the great new challenge will
gait orthosis (assistive technology) and electrical muscle
be the convergence of neural prosthetics with neural re-
stimulation components which power, in part, the ortho-
generation for restoration of function taking into ac-
sis. These may develop to fully implantable systems [9].
count the current limits of stimulation technology. The
This approach may come to a higher level of develop-
most powerful treatment strategies will be those that
ment if we manage to compensate not only for the motor
combine technical innovations, biological approaches
but also for the sensory deficit in spinal cord injury
and regenerative therapies that work together, interact
patients with the application of closed-loop systems,
and amplify the efficacy of each other.
extracting information from either natural sensors (cuta-
neous, muscular or joint) or from cutaneous mechanore-
ceptors in order to control, with the use of a ‘‘neural
Epilogue
controller’’ network, FES-based neural prostheses [2].
Undoubtedly, the limitations of existing neuroprostheses Practitioners and researchers in neuromodulation
should challenge us to identify new directions for con- should have a forward-looking perspective and envision
tinued research and development towards more com- a new era of breakthroughs in the field. There are, how-
10 D. E. Sakas et al.: An introduction to operative neuromodulation and functional neuroprosthetics

ever, certain major issues that need to receive our full continuously evolving practice of neuromodulation. The
attention in order to see further progress. Firstly, as pre- reader will be the judge of our success in meeting these
viously stated, it is important to develop guidelines and a goals.
better classification of the groups of patients who should
receive neuromodulation. Secondly, we must utilize to
References
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Correspondence: Damianos E. Sakas, P. S. Kokkalis Hellenic Center
current medical practice and research into this area. It is for Neurosurgical Research, 3 Ploutarchou Str, Athens 10675, Greece.
hoped that this book will have a positive impact in the e-mail: [email protected]
Acta Neurochir Suppl (2007) 97(1): 11–19
# Springer-Verlag 2007
Printed in Austria

Electricity in the treatment of nervous system disease

H. Fodstad1 and M. Hariz2

1
Veterans Affairs Medical Center, New York, USA
2
Institute of Neurology, London, UK

Summary Neron and physician to the Roman Emperor Claudius

Electricity has been used in medicine for almost two millenniums applied electrical currents from the torpedo fish to treat
beginning with electrical chocks from the torpedo fish and ending with headaches and painful gout [61, 94]:
the implantation of neuromodulators and neuroprostheses. These im-
plantable stimulators aim to improve functional independence and qual- ‘‘A chronic and intolerable headache which insis-
ity of life in various groups of disabled people. New indications for tently manifests itself can be eliminated at once if treat-
neuromodulation are still evolving and the field is rapidly advancing.
ed by applying a live torpedo fish, black in color, to the
Thanks to modern science and computer technology, electrotherapy has
reached a degree of sophistication where it can be applied relatively site of the pain and leaving it there until the pain stops
safely and effectively in a variety of nervous system diseases, including and the part is swollen.’’
pain, movement disorders, epilepsy, Tourette syndrome, psychiatric dis-
ease, addiction, coma, urinary incontinence, impotence, infertility, re- The real breakthrough for electrotherapy came with
spiratory paralysis, tinnitus and blindness. the scientific progress of the 18th century, especially af-
Keywords: Deep brain stimulation; electricity; electrotherapy; ner- ter the discovery of the Leyden jar in 1746 [11]. In 1777,
vous system; neuromodulation; neuropacemaker; neuroprosthesis; neu- Cavallo published ‘‘A complete treatise on electricity,
rostimulation; stereotaxy.
in theory and practice, with original experiments.’’ He
reported cures of epilepsy, paralysis, chorea, deafness,
‘‘Is it a fact – or have I dreamt it – that by means of blindness, rheumatism and glandular enlargement. He
electricity, the world of matter has become a great was also the first to recommend electricity as means of
nerve, vibrating thousands of miles in a breathless point artificial respiration [11]. As early as 1774, Benjamin
of time? Rather, the round globe is a vast head, a brain, Franklin noted muscle contractions on exposure to static
instinct with intelligence; or shall we say it is itself a electricity [43]. After Franklin’s invention of lightning
thought, nothing but thought, and no longer the sub- rods in 1775, there were three important milestones in
stance which we dreamed it.’’ the history of electrotherapy: The discovery of animal
Nathaniel Hawthorne (1804–1864) electricity by Luigi Galvani in 1787, the discovery of bi-
metallic electricity by Alessandro Volta in 1794 and the
discovery of inductive electricity by Michael Faraday in
Historical background
1831 [34, 81] (Table 1). Volta also invented the first elec-
By definition, electricity is a fundamental entity of tric battery in 1800. In 1804 Aldini, a nephew of Galvani,
nature consisting of negative and positive charges, ob- recommended galvanism for deafness, insanity, amauro-
servable in the attractions and repulsions of bodies elec- sis, and to produce artificial respiration [11].
trified by friction and natural phenomena, and usually Andrew Ure in 1818 used the body of a hanged crim-
utilized in the form of electric currents. inal immediately after execution to stimulate the phrenic
The first known use of electricity in medicine was nerves in the chest with galvanic electricity, thereby pro-
in AD 46 when Scribonius Largus, a pharmacist from ducing contractions of the diaphragm [106]. He thought