Epidural Stimulation After Neurologic Damage

Study Overview
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Brief Summary
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This study will evaluate a method to optimize parameter settings in epidural spinal cord stimulation used to recover lower extremity volitional movement. The study will also characterize improvement in autonomic function (such as blood pressure control) and other functions related to spinal cord injury.

Detailed Description
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Epidural spinal cord stimulation for the purpose of facilitating volitional movement is a new and novel neuromodulatory treatment. Epidural SCS has a long history of use for chronic pain with established medical device platforms. The purpose of this study is to investigate and establish the use of SCS for volitional movement. Specifically, establishing the disinhibitory effect of SCS in a greater population with inherent greater variability. In addition to establishing the disinhibitory effect of SCS for cSCI, our study attempts to explore the parameter space of the spinal cord stimulator platforms in order to optimize stimulation settings for patients through the creation of a clinical decision support system (CDSS). Preliminary evidence suggests benefit to autonomic function, and this study also begins to explore the effects of SCS on cardiovascular function, urinary function, psychiatric outcomes, and quality of life, which all offer significant potential for patients suffering from chronic spinal cord injury.

Official Title
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Epidural Stimulation for Spinal Cord Injury

Conditions
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Spinal Cord Injuries, Paraplegia, Complete

Intervention / Treatment
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* Device: Epidural Spinal Cord Stimulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 22 years of age or older Able to undergo the informed consent/assent process Stable, motor-complete paraplegia Discrete spinal cord injury between C6 and T10 ASIA A or B Spinal Cord Injury Classification Medically stable in the judgement of the principal investigator Intact segmental reflexes below the lesion of injury Greater than 1 year since initial injury and at least 6 months from any required spinal instrumentation Willing to attend all scheduled appointments Exclusion Criteria: Diseases and conditions that would increase the morbidity and mortality of spinal cord injury surgery (e.g. cardiopulmonary issues) Inability to withhold antiplatelet/anticoagulation agents perioperatively Significant dysautonomia that would prohibit rehabilitation or assisted standing or any history of CVA or MI associated with autonomic dysreflexia. A single tilt table test with syncope, presyncope, or SBP < 50 or >200. Other conditions that would make the subject unable to participate in testing/rehabilitation in the judgement of the principal investigator Current and anticipated need for opioid pain medications or pain that would prevent full participation in the rehabilitation program in the judgement of the principal investigator Clinically significant mental illness in the judgement of the principal investigator Botulinum toxin injections in the previous 6 months Volitional movements present during EMG testing in bilateral lower extremities Unhealed spinal fracture Presence of significant contracture Presence of pressure ulcers Recurrent urinary tract infection refractory to antibiotics Current Pregnancy

Ages Eligible for Study
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Minimum Age: 22 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: All subjects will receive study intervention. Outcome assessments will be tested while the stimulator unit is on (intervention) and off (sham) during the study.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epidural Spinal Cord Stimulation<br>Epidural Spinal Cord Stimulation | Device: Epidural Spinal Cord Stimulation<br>* epidural spinal cord stimulator<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Volitional Response Index Magnitude | Brain Motor Control Assessment Volitional Response Index Magnitude | Months: 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spinal cord stimulation for cardiovascular function | Systolic blood pressure measured during epidural stimulation (continuous) | Over 12 months | 
| Cerebrovascular Assessment Change | Cerebral blood flow (CBF) during tilt table | Months: 3, 6, 9 | 
| Change in Visual Neurocognitive Assessment | Stroop Test | Months: 3, 6, 9 | 
| Spinal cord stimulation optimization | Probit preference response surface obtained by serial force binary choice | Over 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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epidural stimulation, spinal cord stimulation, autonomic dysfunction