Recovery of Cardiovascular Function With Epidural Stimulation After Human Spinal Cord Injury

Study Overview
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Brief Summary
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We propose to demonstrate that epidural stimulation (ES) can be used to recover significant levels of autonomic control of cardiovascular and respiratory function as well as the ability to voluntarily control leg movements below the injury level. This intervention would provide an immediate therapeutic alternative to individuals who now have no recourse for treatment.

Detailed Description
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We will enroll 4 research participants who have sustained a motor complete SCI to participate in the proposed experiments. Participants will be screened for eligibility, followed by 80 days of usual care, epidural implantation, 80 days of cardiovascular epidural stimulation training, 80 days of voluntary movement (VM) epidural stimulation training and finally 80 days of stand epidural stimulation training. These interventions are done in sequential order, however they are cumulative. In between each intervention, participants will undergo motor and cardiovascular experiments and assessments.

Official Title
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Recovery of Cardiovascular Function With Epidural Stimulation After Human Spinal Cord Injury

Conditions
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Spinal Cord Injury

Intervention / Treatment
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* Device: 5-6-5 Specify electrode
* Device: Restore Advance Pulse Generator


Participation Criteria
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Eligibility Criteria
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non-progressive SCI with complete motor paralysis above T1; American Spinal Injury Association Impairment Scale (AIS) A, B or C; 21 - 70 years of age; greater than 2 years post injury; stable medical condition; unable to voluntarily move all single joints of the legs; cardiovascular dysfunction including presence of persistent resting blood pressures and/or symptoms of autonomic dysreflexia and/or orthostatic hypotension; and respiratory dysfunction including at least 15% deficit in predicted pulmonary function outcomes; Exclusion Criteria: ventilator dependent; painful musculoskeletal dysfunction, unhealed fracture, contracture, or pressure sore that might interfere with training; clinically significant depression or ongoing drug abuse; cardiovascular, respiratory, bladder, or renal disease unrelated to SCI; severe anemia (Hgb<8 g/dl) or hypovelemia; and HIV or AIDS related illness.

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 70 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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epidural Stimulation<br>80 sessions each of epidural spinal cord stimulation for 1) cardiovascular function; 2) voluntary movement; and 3) standing. | Device: 5-6-5 Specify electrode<br> <br> Device: Restore Advance Pulse Generator<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Arterial Blood Pressure in Response to Epidural Stimulation | Noninvasive continuous blood pressure measured from a finger cuff by plethysmographic technique (Finometer Pro, FMS, Amsterdam, Netherlands) was calibrated to brachial blood pressure. Mean arterial pressure was calculated as one-third of systolic blood pressure plus two-third of diastolic blood pressure. | 20 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Epidural Stimulation