Wearable Electrical Stimulation on the Back to Modulate Spinal Cord Activity

Study Overview
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Brief Summary
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The goal of this study is to evaluate if non-invasive electrical spinal stimulation can help people with paralysis caused by SCI improve strength and function of their arms, legs, hands or feet. The study will involve therapy sessions involving exercises done at the same time as electrical stimulation therapy. This study has multiple parts to evaluate the effectiveness and safety of smart electrical stimulation of the spinal cord, which involves stimulating the spinal cord at precise locations and times to improve movement and function.

Detailed Description
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This trial is investigating the use of transcutaneous spinal cord stimulation, where the electrical stimulation is delivered non-invasively via surface electrodes placed on the skin along the spine. The trial will have two phases: open-loop transcutaneous spinal cord stimulation (SCS) phase (where stimulation parameters are selected and subsequently fixed for each stimulation sessions) and closed-loop transcutaneous SCS phase, (where stimulation parameters are continuously revised in real-time during each session based upon the exact movement state of the person as captured by wearable kinematic and electromyographic sensors). For both open-loop and closed-loop phases, the transcutaneous spinal cord stimulation will be incorporated into Functional Task Practice (FTP) sessions guided closely by a team of trained technicians and occupational and physical therapists. Upon enrollment, participants will complete a baseline assessment of outcome measures validated for spinal cord injury rehabilitation. They will also undergo mapping with sensors of their movements without stimulation to simply characterize their unique motor signature. Then they will undergo the same mapping with open-loop transcutaneous SCS applied to determine if and how stimulation at a variety of settings can modify their unique motor signature. They will then participate in the open-loop phase - 15 open-loop SCS+FTP sessions - after which they will repeat the outcome measures (interim assessment). They will then proceed to the closed-loop phase - 15 closed-loop SCS+FTP sessions - after which they will repeat the outcome measures a final time (endpoint assessment).

Official Title
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The Reynolds Innovative Spinal Electrical Stimulation (RISES) Program: Transcutaneous Spinal Cord Stimulation

Conditions
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Spinal Cord Injuries, Spinal Cord Diseases

Intervention / Treatment
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* Device: RISES-T System
* Other: Occupational/Physical Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has a non-progressive or central cord spinal cord injury from C2-T10 inclusive Has American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification B, C, or D Can participate in physical and occupational therapy rehabilitation programs Is at minimum 12 months post- spinal cord injury Can provide informed consent Has adequate caregiver support to facilitate participation in study Exclusion Criteria: Has uncontrolled cardiopulmonary disease or cardiac symptoms (as determined by the Investigator) Has diffuse lower motor neuron injury rendering majority of muscles not excitable Has any unstable or significant medical condition that is likely to interfere with study procedures or likely to confound study endpoint evaluations like severe neuropathic pain, depression, mood disorders or other cognitive disorders Has autonomic dysreflexia that is severe, unstable, and uncontrolled or uncontrolled orthostatic hypotension that may interfere with rehabilitation. Requires ventilator support Has an autoimmune etiology of spinal cord dysfunction/injury Has spasms that limit the ability to participate in the study training (as determined by the Investigator) Has skin breakdown in area(s) that will come into contact with electrodes Has any active implanted medical device Is pregnant, planning to become pregnant or currently breastfeeding Has concurrent participation in another drug or device trial that may interfere with this study Has other traumatic injuries such as peripheral nerve injuries, severe musculoskeletal injuries (e.g., shattered pelvis, long bone fractures), that prevent evaluation of response to or participation in rehabilitation. Is deemed ineligible because the investigators believe the study would not be safe or appropriate for the individual

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Arm<br>Participants will receive closed-loop transcutaneous spinal cord stimulation via the RISES-T System while completing functional task practice in occupational therapy sessions. | Device: RISES-T System<br>* Non-invasive closed-loop electrical stimulation of the spinal cord through the skin<br>* Other names: Transcutaneous spinal stimulation;Other: Occupational/Physical Therapy<br>* Exercise therapy to improve function of upper and/or lower limbs<br>* Other names: Functional Task Practice;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline- International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) | Standard neurological assessment for determining level and severity of impairment after spinal cord injury. It includes a sensory exam (dermatological light touch and pin prick) and motor exam (manual muscle strength testing). | Repeated measurements once every 6 weeks throughout the study, an average of 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline - Spinal Cord Independence Measures (SCIM) | Validated measure that evaluates self-care (feeding, grooming, bathing, dressing), respiration and sphincter management, and mobility abilities (transfers and indoor/outdoor). | Repeated measurements once every 6 weeks throughout the study, an average of 3 months | 
| Change from Baseline - Canadian Occupational Performance Measure (COPM) | Participant-centered instrument that measures changes in how participants perceive their own functional performance and challenges in daily living; participants identify goals of most importance to them in areas of functional tasks and occupational performance including self-care, leisure, and productivity. | Repeated measurements once every 6 weeks throughout the study, an average of 3 months | 
| Change from Baseline - Capabilities of Upper Extremity (CUE-T) | Validated objective measure of upper extremity functional capabilities in persons with SCI; evaluates the ability to perform various actions (reach up, pull up, picking up a pencil with tips of fingers). | Repeated measurements once every 6 weeks throughout the study, an average of 3 months | 
| Change from 10 Meter Walk Test (10MWT) and Walking Index for Spinal Cord Injury (WISCI II) | Validated performance measures to assess walking speed and amount of physical assistance needed/assistive devices required for walking respectively. | Repeated measurements once every 6 weeks throughout the study, an average of 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal Cord Injuries, Spinal Electrical Stimulation, Transcutaneous Spinal Stimulation