Neuromodulation. Comprehensive Textbook of Principles, Technologies, and Therapies

NEUROMODULATION
List of Contributors
Foreword
Volume 1
Volume 2
Volume 3
Other Neuromodulation Definitions and Terms
References
Further Reading
XII Neuromodulation for Functional Restoration
INTRODUCTION
References
93 - The History of Neuromuscular Electrical Stimulation—The Evolution of Functional Neuromuscular Stimulation and Future Directions
References
Further Reading
94 - Functional Electrical Stimulation for Return of Function After Stroke
Introduction
Upper-Limb Applications
NMES Applications
FES Applications
Lower-Limb Applications
NMES Applications
FES Applications
Shoulder Pain
Surface NMES
Percutaneous and Implanted NMES
Conclusions
Acknowledgments
References
95 - Invasive Neurostimulation for Poststroke Motor Recovery
Introduction
Proposed Mechanisms Underlying Functional Recovery
Neurostimulation-Based Approaches to Enhance Motor Poststroke Motor Recovery
Noninvasive Brain Stimulation
Vagal Nerve Stimulation (VNS)
Epidural Cortical Stimulation
Deep Cerebellar Stimulation
Future Trends and Pathways
Conclusion
References
96 - Stimulation for Return of Upper-Extremity Function
Historical Perspective
Pertinent Anatomy, Physiology, and Disease Pathophysiology
Rationale for Neuromodulation Target Selection and Approach
Indications and Patient Selection Criteria
Technology Description and User Control
Implant Procedure Details
Programming and Other Points of Consideration
Outcomes
First-Generation Implanted Upper-Extremity Neuroprostheses (IRS-8)
Second-Generation Implanted Upper-Extremity Neuroprostheses (IST-10+IJAT)
Second-Generation Implanted Upper-Extremity Neuroprostheses (IST-12+MES)
Second-Generation Implanted Upper-Extremity Neuroprostheses (High Tetraplegia)
Complications and Avoidance
What the Future Holds
Conclusions
References
Further Reading
97 - Lower Extremity Motor System Neuroprostheses
Neuroprosthetic Options for Restoring or Improving Ambulation
Neuroprostheses for Walking After Incomplete Paralysis
Neuroprostheses for Walking After Complete Paralysis
Hybrid Neuromechanical Systems
Powered Exoskeletons
Future Directions and Challenges
Neuroprostheses for Controlling Seated and Standing Balance
Neuroprosthetic Interventions for Truncal Stability and Active Sitting
Application of Continuous Stimulation
Context-Dependent Stimulation
Future Directions and Challenges
Automatic Control of Standing Balance
Future Directions and Challenges
Neuroprostheses for Recreation and Exercise
References
98 - Neuromodulation of the Spinal Cord for Movement Restoration
Historical Perspective
Spinal Cord Epidural Stimulation Facilitates Stepping and Standing in Mammals
Evidence of Sophisticated Neural Networks in the Human Spinal Cord Circuitry
Spinal Cord Epidural Stimulation Facilitates Standing and Stepping Patterns in Humans
Spinal Cord Epidural Stimulation Evoked Unforeseen Voluntary Movement Responses and Independent Standing in Humans With Motor-Co...
Rationale for Neuromodulation Target Selection and Approach
Programming and Other Points of Consideration
Voluntary Movement
Selection of Epidural Stimulation Parameters for Promoting Voluntary Leg and Trunk Movement
Role of Activity-Based Training With Spinal Cord Epidural Stimulation for Recovery of Motor Function for Voluntary Leg and Trunk...
Standing
Selection of Epidural Stimulation Parameters for Promoting Standing
Role of Activity-Based Training With Spinal Cord Epidural Stimulation for the Recovery of Motor Function for Standing
Stepping
Selection of Epidural Stimulation Parameters for Promoting Standing
Role of Activity-Based Training With Spinal Cord Epidural Stimulation for Recovery of Motor Function for Step Training
Summary and Future Directions
References
99 - A Brief History of the Cochlear Implant and Related Treatments
Introduction
Steps Toward Ever-Better Hearing With Cochlear Implants and Related Treatments
Steps 1–3: From Proof-of-Concept Demonstrations to Multisite Implants
Status of the Field as of the Late 1980s
Step 4: Better Processing Strategies
Status of the Field as of the Mid-1990s
Step 5: Adjunctive Stimulation
The Steps Reprised and the Growth in the Number of Implants Over the Years
Comment About Medical (and Other) Breakthroughs
Recognitions of the Achievement
The Future
Dedication
Acknowledgments
References
100 - Stimulation for the Return of Hearing
Design of Cochlear Implants
Aspects of Normal Hearing
Loss of Hearing
Electrical Stimulation of the Auditory Nerve
Components of Cochlear Implant Systems
Transformation of Input Sounds Into Stimuli for the Implant
Performance With the Present-Day Unilateral Implants
Adjunctive Stimulation
Possibilities for the Future
Acknowledgments
References
101 - The Development of Visual Prosthetic Devices to Restore Vision to the Blind
Epiretinal Prostheses
Second Sight Medical Products
EpiRet
Intelligent Medical Implants
Subretinal Prostheses
Optobionics
Retina Implant AG
Boston Retinal Implant Project
Stanford University
Suprachoroidal Prostheses
Bionic Vision Australia
Department of Visual Science, Osaka University
Summary
References
102 - Neuromodulation for Treatment of Dry Eye
Overview of Dry Eye Disease
Signs, Symptoms, and Diagnosis of Dry Eye
Epidemiology of Dry Eye Disease
Physiology of the Ocular Surface
Tears
Tear Film
Lipid Layer
Aqueous Layer
Mucin Layer
Tear Dynamics
Pathophysiology of Dry Eye Disease
Role of Inflammation in Dry Eye
Anatomy and Physiology of the Lacrimal Functional Unit
Oculolacrimal Neural Pathway
Nasolacrimal Reflex Pathway
Pathophysiology of the Lacrimal Functional Unit
The Intranasal Tear Neurostimulator
Clinical Outcomes With the Intranasal Tear Neurostimulator in Dry Eye
Effects on Aqueous Tear Production
Effects on Tear Components, Goblet Cell and Meibomian Gland Activity
Safety of the Intranasal Tear Neurostimulator
Conclusions
Acknowledgments
References
103 - Neuroprostheses for Restoring Sensation
Introduction
Somatosensation for Prostheses
Benefits
Body-Powered Versus Electrically Powered Prostheses and Somatosensation
Neural Interfaces Are Needed to Restore Somatosensation
Peripheral Nerve Interfaces
Stimulation Parameters and Patterns
Class III Medical Device Status
Clinical Demonstrations of Somatosenstory Restoration
Summary
References
XIII A - Neuromodulation for Cardiovascular Disorders
INTRODUCTION
References
104 - Autonomic Control of the Heart
Cardiac Afferent Neurons
Cardiac Efferent Neurons
Local Circuit Neurons
Interactions Among Autonomic Neurons in the Coordination of Regional Cardiac Indices
Overview
Intrinsic Cardiac Neuronal Interactions
Intrathoracic Extracardiac Reflexes
Central-Peripheral Reflex Interactions in the Coordination of Cardiac Indices
Cardiac Autonomic Dysfunction Secondary to Cardiac Pathology
Conclusion
References
105 - Spinal Cord Stimulation for Peripheral Vascular Disorders
Introduction
History of Electrical Stimulation for Peripheral Arterial Disease
Indications and Patient Selection Criteria
Trial Stimulation and Programming in Peripheral Arterial Disease Patients
Outcomes
Conclusion and Future Expectations
References
Further Reading
106 - Neuromodulation for Refractory Angina and Heart Failure
Neuromodulation for Refractory Angina Pectoris
Definition, Pathology, and Symptomatology of Angina Pectoris
Conventional Treatment for Angina Pectoris
Lifestyle Modification and Pharmacological Treatment
Revascularization
Refractory Angina Pectoris
Definition
Incidence and Prevalence
Patient Characteristics
Treatment of Refractory Angina Pectoris
Historical Perspective of Neuromodulation in Angina Pectoris
Implant Procedure and Stimulation Regime
Implant Procedure
Stimulation Regime
Review of the Most Recent Literature
Safety and Preclinical Studies of Neuromodulation for Myocardial Ischemia
Long-Term Effects of Spinal Cord Stimulation
Placebo-Controlled Trials
Randomized Trials of Spinal Cord Stimulation Versus Other Treatment Modalities
Registry Studies
Systematic Reviews
Clinical Perspective
Patient Selection
Follow-Up
Complications of Spinal Cord Stimulation for Refractory Angina Pectoris
Device Interactions
Neuromodulation for Heart Failure
Definition, Pathology, Symptomatology and Treatment of Heart Failure
Preclinical Studies of Spinal Cord Stimulation in Heart Failure
Clinical Studies of Spinal Cord Stimulation in Heart Failure
Future Perspectives (The Next Five Years)
Conclusions
References
107 - Baroreceptor Activation for Hypertension and Heart Failure
Hypertension: Prevalence and Population Health
The Pathophysiology of Hypertension
Targeting the Sympathetic Nervous System With Modulatory Therapies
Baroreflex Activation Therapy Trial Data
Device-Based Therapy in Hypertension Trial
Rheos Pivotal Trial
Long-Term Rheos Pivotal Trial Patient Follow-Up
Barostim Neo Trial
Carotid Nitinol Device (MobiusHD)
Heart Failure: Prevalence and Population Health
Pathophysiology of Heart Failure
Heart Failure and the Role of Baroreflex Activation Therapy
The Barostim HOPE4HF (Hope for Heart Failure) Study
Long-Term Chronic Baroreflex Activation in Heart Failure With Reduced Ejection Fraction
Discussion and Future Directions
Conclusions
References
XIIII B -
NEUROMODULATION FOR PULMONARY DISORDERS
INTRODUCTION
108 - Upper Airway Neurostimulation to Treat Obstructive Sleep Apnea
Background of the Clinical Problem
Epidemiology
Mechanisms
Current Therapy
Physiologic Studies Supporting Neuromodulation Therapy
Tongue Musculature and Hypoglossal Nerve (HN) Control
Transcutaneous Electrical Stimulation (TES) of Upper Airway Muscles
Initial Demonstration of Hypoglossal Nerve Stimulation (HNS)
Development of Implantable Devices: 2001–13
Closed-Loop Hypoglossal Neurostimulation Devices
Open-Loop Hypoglossal Neurostimulation Devices
Regulatory Trials of Hypoglossal Nerve (HN) Devices
FDA-Approved Inspire II UAS for OSA in Clinical Use
The Inspire Upper Airway System (UAS)
Clinical Selection Criteria
Safety Summary for All Devices
Safety
Other Outcome Measures for Efficacy
Sleep Architecture
Daytime Sleepiness and Sleep-Related Quality of Life (QOL)
Therapy Acceptance and Adherence
Future Directions
Mechanisms and Effects of Stimulation on Upper Airway Physiology
Development of a Preclinical Model for OSA
Improvements in Neurostimulation Devices
Longitudinal Studies of OSA Treated With Hypoglossal Neurostimulation
Conclusion
Acknowledgments
References
109 - A Neural Prosthesis for Obstructive Sleep Apnea
Introduction
Control of Airway Patency Through Tongue Muscles
Prosthetic Design for Obstructive Sleep Apnea (OSA)
Single Electrode Closed-Loop Prosthesis Design for Obstructive Sleep Apnea
Obstructive Sleep Apnea Prosthesis With Selective Stimulation
Clinical Implementation
Conclusion
Acknowledgment
References
110 - Transvenous Phrenic Nerve Stimulation for Central Sleep Apnea
Introduction
Pathophysiology
Treatment Options for Central Sleep Apnea
History of Phrenic Nerve Pacing
A Transvenous Approach to Phrenic Nerve Stimulation: The Remedē System
System Implantation
Therapy Programming
Transvenous Phrenic Nerve Stimulation Clinical Studies
Feasibility Studies
Pilot Study
Remedē System Pivotal Trial
Summary of Clinical Studies
Conclusions
Key Points
Disclosures
References
111 - Neurostimulation for Asthma
Introduction
Asthma: The Scope of the Problem
Basic Science
Clinical Results With Vagus Nerve Stimulation for Bronchoconstriction
The Mechanism of Vagus Nerve Stimulation on Airway Reactivity
Conclusion
References
112 - Stimulation for Inspiration
Background
Current Experience
Future Trends
Conclusion
Conflict of Interest Disclosure
References
113 - Restoration of Cough via Functional Electrical Stimulation
Current Techniques of Secretion Management
Normal Cough Reflex
Experimental Methods to Restore Cough
Spinal Cord Stimulation (SCS) to Restore Cough, Animal Studies
Spinal Cord Stimulation (SCS) to Restore Cough, Human Studies
Electrical Stimulation System
Implementation of the Cough Stimulator Following Surgical Implantation
Results of Applied Electrical Stimulation
Clinical Outcomes
Long-Term Effects of Spinal Cord Stimulation (SCS) to Restore Cough
Cost Benefit Analysis of Spinal Cord Stimulation (SCS) to Restore Cough
Complications and Side Effects
Future Directions
Summary and Conclusions
Acknowledgments
Conflict of Interest Notification
References
XIII C -
NEUROMODULATION FOR GASTROINTESTINAL DISORDERS
INTRODUCTION
114 - Neural Control of the Gastrointestinal System
Introduction
Central Nervous System Control
Extrinsic Control by the Autonomic Nervous System
Intrinsic Gastrointestinal Control Though the Enteric Nervous System
Gastrointestinal Reflexes
Conclusion
References
Further Reading
115 - Spinal Cord Stimulation for Chronic Abdominal Pain
Introduction
Mechanisms of Abdominal Pain
Causes of Chronic Non-Malignant Abdominal Pain
Establishing a Diagnosis
Spinal Cord Stimulation for Chronic Abdominal Pain
Basic Science
Clinical Evidence in Humans
New Modalities of Spinal Cord and Dorsal Root Ganglia Stimulation for the Treatment of the Complexity of Chronic Abdominal Pain
Conclusion
References
116 - Emerging Gastric Stimulation for Dysmotility Disorder and Obesity
Introduction
Gastric Motility and Food Intake
Gastric Myoelectrical Activity and Motility
Roles of Gastric Motility in Food Intake and Digestion
Methods of Gastric Electrical Stimulation
Emerging Gastric Electrical Stimulation for Gastric Motility Disorders
Gastric Pacing for Gastroparesis
Dual-Pulse Gastric Electrical Stimulation for Gastroparesis
Synchronized Gastric Electrical Stimulation
Gastric Electrical Stimulation for Obesity
Implantable Gastric Stimulation
Tantalus
Inhibitory Gastric Electrical Stimulation
Summary
References
117 - Intestinal Electrical Stimulation: Methodologies, Effects, Mechanisms, and Applications
Introduction
Physiology and Pathophysiology of Intestinal Motility
Small Intestinal Motility
Small Intestinal Myoelectrical Activity
Intestinal Motility Disorders
Methodologies
Placement of Stimulation Electrodes
Effects and Mechanisms on Intestinal Functions
Effects of Intestinal Electrical Stimulation (IES) on Intestinal Slow Waves
Effects on Intestinal Slow-Wave Dysrhythmia
Effects and Mechanisms of Intestinal Electrical Stimulation (IES) on Intestinal Motility
Effects and Mechanisms of Intestinal Electrical Stimulation (IES) on Intestinal Transit and Absorption
Effects of Intestinal Electrical Stimulation (IES) on Other Organs
Effects and Mechanism of Intestinal Electrical Stimulation (IES) on Glycemic Control
Potential Applications
Discussion and Conclusions
References
118 - Neuromodulation for Nausea and Vomiting in Adult Patients
Introduction
Neurostimulation
Gastroparesis Syndromes
Clinical Benefits of Gastric Neuromodulation Therapy
Additional Proposed Benefits
New Developments for Gastroparesis and Gastroparetic Syndromes
New Areas of Exploration of Neuromodulation
Summary
References
Further Reading
119 - Neuromodulation for Gastrointestinal Dysmotility in Pediatric Patients
Introduction
Gastric Electrical Stimulation
Sacral Nerve Stimulation
Abdominal Transcutaneous Electrical Stimulation
Future Directions
Conclusion
References
120 - Colonic Electrical Stimulation for Constipation
Single-Channel Stimulation
Multichannel Stimulation
Mechanism of Action (MOA)
Summary
References
XIII D -
Neuromodulation for Urogenital Disorders
INTRODUCTION
Overview
A Brief History of Neuromodulation in Urogenital Disorders
Additional Applications for and Approaches to Neuromodulation for Urogenital Disorders
Future Directions
References
121 - Neurophysiology and Neuroanatomy of the Genitourinary Organs
Introduction
Peripheral Innervation of the Urogenital Organs
Anatomy
Physiology and Pharmacology of Efferent Pathways
Lower Urinary Tract
Genital Organs
Physiology and Pharmacology of Afferent Pathways
Lower Urinary Tract
Genital Organs
Anatomy of Central Nervous Pathways Controlling the Urogenital System
Pathways in the Spinal Cord
Afferent Projections in the Spinal Cord
Efferent Neurons
Spinal Interneurons
Pathways in the Brain
Central Neural Control of the Lower Urinary Tract
Organization of Urine Storage Reflexes
Sympathetic Storage Reflex
Urethral Sphincter Storage Reflex
Organization of Voiding Reflexes
Spinobulbospinal Micturition Reflex Pathway
Suprapontine Control of Micturition
Spinal Micturition Reflex Pathway
Neurotransmitters in Central Micturition Reflex Pathways
Excitatory Neurotransmitters
Inhibitory Neurotransmitters
Neurotransmitters With Mixed Excitatory and Inhibitory Actions
Central Neural Control of the Genital Organs
Penile Erection
Glandular Secretion
Emission-Ejaculation
Neurotransmitters in Central Sexual Reflex Pathways
References
122 - Sacral Nerve Neuromodulation
Introduction
Mechanism of Action (MOA)
Sacral Neuromodulation Procedure
One-Stage Implantation
Two-Stage Implantation
Outcomes
Complications
Summary
References
123 - Sacral Nerve Root Stimulation for Bladder Pain Syndrome/Interstitial Cystitis
Background and Definitions
Epidemiology of Bladder Pain Syndrome
Etiology and Pathophysiology
Diagnostic Evaluation
Clinical Management of Bladder Pain Syndrome
First Line: Conservative Therapies
Second Line: Oral Therapies
Second Line: Intravesical Therapies
Third Line: Cystoscopic Techniques
Fourth Line: Other Treatments
Fifth Line: Open Surgery
Sacral Nerve Stimulation
Pelvic Neuroanatomy
Historic Overview
Rationale Behind Neuromodulation for Chronic Painful Conditions of the Pelvis and Painful Bladder Syndromes
Indications and Contraindications for Sacral Nerve Root Stimulation
Preoperative Assessment
Techniques of Sacral Nerve Stimulation
Sacral Transforaminal Approach
The Retrograde (Cephalocaudal) Approach
Anterograde (via Sacral Hiatus) Approach
Retrograde Laminotomy Technique
Programming
Summary of Evidence of Efficacy and Complications
Conclusion
References
Further Reading
124 - Restoration of Bladder and Bowel Control After Spinal Cord Injury
History of the Topic
History of the Problem
History of Current Solutions
Review of the Current Knowledge Base of the Topic
Clinical Effects
Single-Center Results
Multicenter Results
Reliability
Quality of Life, Cost-Effectiveness, and Economic Consequences
Safety and Efficacy Data in the United States
Discussion of Future Trends and Pathways to Expanding the Knowledge Base
References
XIV - Neuromodulation for Endocrine, Immune, and Inflammatory Disorders
INTRODUCTION
Neuromodulation for Inflammatory Diseases
Neuromodulation to Regulate Hemostasis
Neuromodulation for Inflammatory Bowel Disease
Neuromodulation for Diabetes
Neuromodulation to Regulate Pain
Neuromodulation to Regulate Diseases of the Heart
Decoding Neural Signals for Closed-Loop Neuromodulation and Advanced Diagnostics
Closing Remarks
125 - Vagus Nerve Stimulation and Regulation of Inflammation
Therapeutic Challenges in Inflammatory Disease
The Nervous System is an Integral Part of the Immune System
The Inflammatory Reflex
The Inflammatory Reflex in Experimental Disease
Vagus Nerve Stimulation in Experimental and Clinical Disease
Bioelectronic Medicine
Conclusions
References
126 - Activation of the Inflammatory Reflex in Rheumatoid Arthritis and Inflammatory Bowel Disease; Preclinical Evidence
Introduction
Structure and Function of the Cholinergic Antiinflammatory Pathway
Preclinical Evidence for Cholinergic Antiinflammatory Pathway Effect in Models of Rheumatoid Arthritis
Preclinical Evidence for Cholinergic Antiinflammatory Pathway Effect in Models of Inflammatory Bowel Disease
Summary
References
127 - Bioelectronic Therapy for the Treatment of Rheumatoid Arthritis and Inflammatory Bowel Disease
Introduction
The First Clinical Study of Vagus Nerve Stimulation in Patients With Rheumatoid Arthritis
The First Clinical Studies of Vagus Nerve Stimulation in Patients With Inflammatory Bowel Disease
Summary of Clinical Safety Data
Development of an Application-Specific Investigational VNS System for RA and IBD
Future Directions: Toward a Universally Implantable and Closed-Loop Device Platform
Summary
References
128 - Vagal Nerve Stimulation Versus Sacral Nerve Stimulation for Control of Inflammation
Introduction
Cholinergic Antiinflammatory Pathway
Vagal Nerve Stimulation for Intestinal Inflammation
Vagal Nerve Stimulation in Animal Models of Inflammatory Bowel Disease
Vagal Nerve Stimulation for Inflammatory Bowel Disease
Potential of Noninvasive Vagal Nerve Stimulation for Inflammatory Bowel Disease
Sacral Nerve Stimulation for Intestinal Inflammation
Sacral Nerve Stimulation for Proctitis
Sacral Nerve Stimulation for Intestinal Inflammation
Possible Antiinflammatory Pathway of Sacral Nerve Stimulation
References
Further Reading
129 - Neuromodulation Therapies for Cardiac Disease
Introduction
Vagus Nerve Stimulation
Stimulation Method
Neuromodulation Mechanism of Vagus Nerve Stimulation
Vagus Nerve Stimulation and Heart Failure
Vagus Nerve Stimulation and Myocardial Infarction
Vagus Nerve Stimulation and Arrhythmias
Spinal Cord Stimulation
Stimulation Method
Neuromodulation Mechanism of Spinal Cord Stimulation
Spinal Cord Stimulation and Refractory Angina Pectoris
Spinal Cord Stimulation and Heart Failure
Spinal Cord Stimulation and Myocardial Infarction
Spinal Cord Stimulation and Arrhythmia
Carotid Body Ablation and Neuromodulation
Method of Carotid Body Ablation
Neuromodulation Mechanism of Carotid Body Ablation
Baroreceptor Stimulation
Stimulation Method
Neuromodulation Mechanism of Baroreceptor Stimulation
Renal Denervation
Method of Denervation
Neuromodulation Mechanism of Renal Denervation
Autonomic Regulation Therapy: Cardiac Afferent Targets
Conclusion
References
Further Reading
130 - The Neural Tourniquet
Introduction
The Inflammatory Reflex
Traumatic Hemorrhage
Bleeding in Clinical Medicine
The Neural Tourniquet
Swine Ear Hemorrhage
Rodent Liver Hemorrhage
Murine Tail Hemorrhage
Murine Hemophilia A
Clinical Applications
Conclusions
References
131 - Sensing and Decoding Neural Signals for Closed-Loop Neuromodulation and Advanced Diagnostics in Chronic Disease and Injury
Introduction
Sensing, Neural Decoding, and Closed-Loop Neuromodulation
Neuroimaging Techniques for Advanced Diagnostics
Minimally Invasive Neurosensing Techniques for Advanced Diagnostics
Invasive Neurosensing Methods for Advanced Diagnostics
Conclusion
References
Further Reading
132 - The Role of Vagus Nerve Stimulation in the Treatment of Central and Peripheral Pain Disorders and Related Comorbid Somatoform Conditions
History and Background of Vagus Nerve Stimulation (VNS)
Neuroanatomy of the Vagus Nerve and Selective Activation by Vagus Nerve Stimulation
Evidence of Neurotransmitter Modulation
The Noradrenergic and Cholinergic Antiinflammatory Pathways, Linking the Autonomic Nervous System With Inflammation
Central Sensitization Through Persistent, Peripheral, Pain Activation, and Inflammation
The Comorbidity of Pain and Somatoform Disorders
Vagus Nerve Stimulation Opposes the Feed-Forward Loop of Inflammation, Neurotransmitter Imbalance, and Neuronal Hyperexcitabilit...
Clinical Evidence of Vagus Nerve Stimulation for the Treatment of Central and Peripheral Pain Disorders and Their Somatoform Com...
Conclusion
References
133 - Insulin Resistance, Glucose Metabolism, Inflammation, and the Role of Neuromodulation as a Therapy for Type-2 Diabetes
Overview
Background
The Role of Inflammation in Insulin Resistance
Inflammatory Cytokines Inhibit the Production of Glycogen
Key Antiinflammatory Pathways and Their Roles in Glucose Homeostasis
Acetylcholine Blocks Hepatic Glucose Output and Enhances Glycogen Synthetase
Vagus Nerve Stimulation Blocks Inflammatory Pathways
Possible Relevance of Innervation of the White Adipose Tissue
Clinical Evidence of VNS Reducing Insulin Resistance in Humans
Conclusion
References
XV -
Noninvasive Neuromodulation
INTRODUCTION
References
134 - Transcranial Magnetic Stimulation
Brief Introduction
Basic Mechanisms of TMS and TMS as a Tool to Investigate Human Brain Cortex Physiology
Distance Between the Coil and the Cortex
Coil Orientation and Shape
Transcranial Magnetic Stimulation to Probe Cortical Excitability, Inhibitory, and Facilitatory Mechanisms
Single Pulse Transcranial Magnetic Stimulation
Cortical Silent Period
Paired Pulse
Intracortical Facilitation
Short Intracortical Facilitation
Long Interval Intracortical Inhibition
Paired Pulse to Probe Interhemispheric, Cerebellar, and Afferent Inhibition
Transcranial Magnetic Stimulation to Change Brain Activity
Traditional Repetitive Transcranial Magnetic Stimulation
Patterned Repetitive Transcranial Magnetic Stimulation
Paired Associative Stimulation
Clinical Applications of Repetitive Transcranial Magnetic Stimulation
Depression
Pain
Stroke
Safety of Transcranial Magnetic Stimulation
Conclusions
Acknowledgments
References
135 - Transcranial Direct Current Stimulation (tDCS)
Introduction
Historical Background and Other Transcranial Electrical Stimulation Approaches
Developments From Electrosleep to Cranial Electrotherapy Stimulation
Developments From Electroanesthesia to Limoge Current and Other Related Methods
Development of Direct Current Stimulation
Transcranial Direct Current Stimulation Customization
Transcranial Direct Current Stimulation Terminology
Transcranial Electrical Stimulation and Transcrianial Direct Current Stimulation “Dosage”
Origins of Specificity During Transcranial Direct Current Stimulation: Anatomical, Activity-Selective, and Input-Bias Mechanisms...
Anatomical Transcranial Direct Current Stimulation Specificity and the “Sliding-Scale” Model
Activity-Selectivity and Task-Specific Modulation
Input-Selectivity and Bias
Preparation for Transcranial Direct Current Stimulation Stimulation
Selecting and Preparing Electrodes and Contact Medium
Selecting and Preparing Electrode Placement
Computational Models of Transcranial Direct Current Stimulation for Electrode Placement
Common Montages
Methods for the Generation and Use of Computational Forward Models of Transcranial Direct Current Stimulation
Safety Considerations for Transcranial Direct Current Stimulation
Transcranial Direct Current Stimulation Safety Data From Human Trials and Models
Efficacy
References
136 - Transcranial Alternating Current Stimulation and Transcranial Random Noise Stimulation
Introduction
Transcranial Alternating Current Stimulation
Studies With Animals
Mechanism of Action
The Effects of Transcranial Alternating Current Stimulation on Cognition
Random Noise Stimulation
A Special Case of Transcranial Random Noise Stimulation: Transcranial Pulsed Current Stimulation
Mechanism of Action
The Effects of Random Noise Stimulation on Cognition
Clinical Effects of Alternating (tACS) and Random Noise (tRNS) Stimulation
Conclusions
References
137 - Novel Methods of Transcranial Stimulation: Electrosonic Stimulation
Introduction
Noninvasive Electromagnetic Methods
Transcranial Magnetic Stimulation
Transcranial Direct Current Stimulation
Nonelectromagnetic Techniques
Acoustic Stimulation
Electrosonic Stimulation
Conclusions
Acknowledgments
References
138 - Optimization of Noninvasive Brain Stimulation Clinical Trials
Introduction
How to Stimulate Stimulation Parameters
Where to Stimulate Brain Region Targets of Interest
When to Stimulate Timing of Stimulation
Patient Selection Considerations
Combinations of Therapies
Summary of Clinical Effects
Repetitive Transcranial Magnetic Stimulation
Transcranial Direct Current Stimulation
The Future of NIBS
References
139 - Transcranial Direct Current Stimulation for Fatigue and Attentional Disorders
Introduction
Medical Causes of Fatigue and Chronic Fatigue Syndrome
Nonmedical Sources of Fatigue
Transcranial Direct Current Stimulation as a Countermeasure for Fatigue
Attention and Vigilance
Transcranial Direct Current Stimulation’s Effects on Attention and Vigilance
References
XVI -
THE BUSINESS END OF NEUROMODULATION
INTRODUCTION
140 - Perspectives on the Issues and Barriers to Starting a New Neuromodulation Company From New Start-Ups in Neuromodulation
Introduction
My Perspectives on Starting a New Start-Up in Neuromodulation
Industry Challenges: Perspectives on Starting a Neuromodulation Start-Up Company
Starting a Neuromodulation Company and Bringing It to Fruition
Launching a Start-Up
An Idea
Unmet Needs and Validated Market
Compelling Financials
Scientific Foundation
Clinical Data and Intellectual Property
Team
Lessons Learned
Moving Experience to Developing a New Platform for Neuromodulation
Step One: Grounded Engineering and Entrepreneurship Background; a Bit of My History
Step Two: A Technology Is Born
Step Three: Neuromodulation Miniaturization for Pain Relief
Step Four: Technology Hurdles
Step Five: Lifelong Regulatory Compliance and Clinical Evidence
Step Six: Market Awareness and Distribution of the Minimally Invasive Solution
141 - The Birth of an Industry
Early Neuromodulation Devices
The 21st Century Neuromodulation Industry
2001
2002
2003
2004
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
2016
Competitive Landscape
Future Outlook
References
142 - Neuromodulation: Regulatory Considerations
Brief History of Medical Device Regulation
Time and Cost of Device Development
Investigational Device Exemption (IDE)
Determining Whether an Investigational Device Exemption (IDE) Is Needed
Investigational Device Exemption (IDE)-Exempt Studies
Nonsignificant Risk Studies
Implant
Serious Risk to Health
Supporting or Sustaining Human Life
Early Feasibility Investigational Device Exemption
The Case for an Investigational Device Exemption
Device Classification
FDA’s Classification Process
Classification of Neuromodulation Devices
Market Approval for Neuromodulation Systems
Premarket Application (PMA)
Traditional 510(k)
De Novo 510(k)
Humanitarian Device Exemption (HDE)
Innovation Pathway and Expedited Access Pathway
Postmarket Regulation of Neuromodulation Devices
Conclusions
References
143 - Reimbursement for Neuromodulation Therapies and Technologies
Introduction
Reimbursement Structure for Neuromodulation Therapies and Technology in the United States of America
Regulatory and Insurance Approval for the Technique
Background
From US Food and Drug Administration (FDA) Approval to Insurance Approval: “On-Label” Indications
Financial Reimbursement for the Procedure
Hospital/Facility Reimbursement
Physician Reimbursement
Bundled Payments
The Affordable Care Act (ACA) and the Future
Final Thoughts
Reimbursement Structure for Neuromodulation Therapies and Technology in the United Kingdom and Europe
Introduction
United Kingdom
Belgium
The Netherlands
Sweden
Germany
Conclusion
Reimbursement Structure for Neuromodulation Therapies and Technology in South America
South America in the World
Economy and Health
Types and Distribution of Health Coverage
Special Coverage Programs in High-Cost Therapies
Heath Public Spending Distribution
Health Adjudication
The Role of Neuromodulation Societies Regarding the Reimbursement of Reuromodulation Devices
Sistema Único de Reembolso (SUR) or Unique Reimbursement System
Programa Provincial de Neuromodulación (PPN), Neuromodulation Provincial Program
Optimization in the Allocation and Use of Resources
References
144 - Perspective on How to Build a Neuromodulation Practice*
Introduction by Elliot Krames, Editor, Neuromodulation, 2nd Edition
Perspective of Giancarlo Barolat, MD, Neurosurgeon, Denver, Colorado
Perspectives of Alon Mogilner, MD, PhD, Neurosurgeon, Great Neck, NY
Collaborate, but With the Appropriate Collaborators!
Utilize Physician Extenders
What Do You Want to Do
Interventional Pain Physicians: Competitors and Referral Sources
Deep Brain Stimulation
Know the Economics of Your Health Care Environment
Learn Lesioning Procedures
Intrathecal Drug Delivery Systems for Chronic Pain: Do Not Manage, but Do Not Be a Technician
Remember: These Are Your Patients for Life!
Perspectives of Joshua Prager, MD, Anesthesia Pain Management, Los Angeles, CA
Index
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