Epidural Stimulation After Neurologic Damage: Long-Term Outcomes

Study Overview
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Brief Summary
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This study will evaluate the long-term effect of chronic spinal cord stimulation to restore volitional movement for patients with chronic spinal cord injuries.

Detailed Description
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Participants will be enrolled in this study for the duration of 10 years. They will need to come to Minneapolis twice a year for the Brain Motor Control Assessment and will be given different settings within their Spinal Cord Stimulator (SCS) programing.

Official Title
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Epidural Stimulation After Neurologic Damage: Long-Term Outcomes

Conditions
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SCI - Spinal Cord Injury

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 process Stable spinal cord injury International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) neurologic level of injury below C5 No ventilator dependency within the last year American Spinal Injury Association (AISA) imparement scaleA or B in the absence of spinal cord stimulation Medically stable in the judgment of the Principal investigator Greater than 1 year since initial injury and at least 6 months from any required spinal instrumentation and 2 months from spinal cord stimulator surgery Has an existing and functional implanted spinal cord stimulator system that is FDA approved and can be corroborated by hospital documentation Spinal imaging of the stimulator system Exclusion Criteria: Current and anticipated need for opioid pain medications or pain that would prevent full participation in the rehabilitation program in the judgment of the principal investigator Use of botulinum toxin (Botox) injections in the previous six months Clinically significant mental illness in the judgment of the principal investigator Other conditions or medications that would make the subject unable to participate in testing/rehabilitation in the judgment of the principal investigator Nonfunctional spinal cord stimulator or near end-of-life, determined by the PI Current Pregnancy Current pain relief from the spinal cord stimulator if the indication for implantation was for management of chronic pain.

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Volitional EMG power<br>Assessing the change in volitional EMG power during the Brain Motor Control Assement (BMCA) between nonstimulation baseline and stimulation. | Device: Epidural Spinal Cord Stimulation<br>* Stimulation of the spinal cord from the epidural space.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Volitional electromyography (EMG) power | The measurement of volitional change using EMG during the Brain Motor Control assessment between nonstimulation baseline and stimulation | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prediction of power preferences | Prediction of power of preference models built based on evaluations of stimulation settings. | 10 years | 

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