Non-Invasive Electrical and Magnetic Neuromodulation in Persons With Chronic Spinal

Study Overview
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Brief Summary
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The objectives of this study are to (1) determine the effects of neuromodulation techniques on mobility in persons with chronic SCI, as measured by subjective and objective measures, and (2) to determine the optimal combination of techniques that modify mobility and movement in an individual. The neuromodulation techniques explored will be methods of electromagnetic stimulation - that is, electrical stimulation and magnetic stimulation.

Detailed Description
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The study is designed in two Parts. Part 1 of the study will collect information about the participant's baseline mobility and muscular activation potential. The information collected in these sessions will, in effect, assess the participant's eligibility to continue in the study and move onto Part 2. Part 1- Assessment Sessions This part of the study designed to determine (1) which, if any, of the participant's muscles respond to stimulation and, if there are responses observed, (2) what stimulation parameters and modalities would be best suited for the participant during Part 2 of the trial. The team will create a participant-specific menu of modalities and pre-defined parameters for electromagnetic stimulation (e.g., amplitude, channels, frequencies, electrode placement, etc.) from which they will select for participant visits in Part 2 of the study. They will also capture the participant's Movement Signature (the pattern of movement as measured by accelerometers and surface EMG that a person exhibits while sitting/standing at rest and/or doing specific tasks to inform Part 2 of the study. Finally, the participants will complete a Baseline Clinical Outcome Measures validated for SCI to provide baseline data prior to the neuromodulation intervention. Part 2 - The Experimental Cycles This part of the study will consist of Intervention Sessions, in which the team will apply transcutaneous stimulation to the participant's target muscles identified in Part 1, using the parameters and modalities deemed best suited for the participant. during tasks and activities deemed most appropriate for the targeted muscles. The team will measure the effects of electromagnetic stimulation on the participant's muscle activity and movement. The Cycle will also include Biometric sessions, where the participant will engage in a series of upper extremity, trunk and/or lower extremity repetitive tasks from their prescribed activity library that was created for them during Part 1 of the study and the team will measure changes in muscle tone, strength, and movement before and after stimulation. In other sessions, the participant will undergo a series of more targeted tasks with and without electromagnetic stimulation applied, to measure changes in the participant's neurophysiology, kinetics, and kinematics due to electromagnetic stimulation. After a series of Intervention and Biometrics Sessions, if there are no changes observed in the participant's kinematics or EMG signals in the and/or in select outcome measures, the participant will enter a Parameter Optimization Session. During this session, the study team will revisit the library of stimulation parameters that were defined for the participant during Part 1 of the study and refine the parameters for use in the next Experimental Cycle. The manipulation and refinement of these parameters will be done with the aim of achieving changes in the subsequent Experimental Cycle. The participant will continue in the study until the time that there is no observed effect of stimulation for three (3) consecutive Experimental Cycles, or may continue for a maximum of six (6) Experimental Cycles. At the end of the study, the participant will repeat the series of Clinical Outcome Measures that were completed at Baseline.

Official Title
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The Reynolds Innovative Spinal Electrical Stimulation Program: Transcutaneous Stimulation (RISES-T 2.0)

Conditions
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Spinal Cord Injuries, Spinal Cord Diseases

Intervention / Treatment
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* Device: RISES-T System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has a non-progressive or central cord spinal cord injury American Spinal Injury Association (ASIA) Impairment Scale (AIS) classification A, B, C, or D Can participate in physical and occupational therapy rehabilitation programs Is at minimum 12 months post-injury Can provide informed consent Has adequate caregiver support to facilitate participation in study Is willing to undergo audio-visual recording sessions - Exclusion Criteria: Has uncontrolled cardiopulmonary disease or cardiac symptoms (as determined by investigators) 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 (e.g., cochlear implant, pacemaker, neurostimulator or medication infusion 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 not a candidate for other reason determined by the investigators -

Ages Eligible for Study
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Minimum Age: 18 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: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, unblinded, feasibility study where participants will serve as their own controls.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Treatment Arm<br>Participants will receive closed-loop transcutaneous spinal cord stimulation via the RISES-T System while completing repetitive task practice | Device: RISES-T System<br>* The RISES-T system is a hardware and software platform that has been designed and developed to help people living with movement impairment due to Spinal Cord Injury (SCI) to improve and/or restore mobility. The hardware consists of a functional electrical stimulation device that delivers stimulation to the skin through surface electrodes; a series of wearable sensors that collect kinematic (IMU) data and muscle activity (EMG) data, and RISES Software, which incorporates algorithms that utilizes the streaming IMU and EMG sensor data to inform the electrical stimulation parameters and enables real-time visualization of the sensor data and stimulation parameters via Graphical User Interface (GUI).<br>* Other names: Trancutaneous spinal stimulation;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spinal Cord Injury-Motor Index (SCI MovIN) | evaluates movement, and recovery of neurotypical movement, within a functional context that accounts for compensations and disallows substitutions | Starting 4 weeks after consent, 3 times every 2 weeks for up to 22 weeks | 
| Modified Ashworth Scale (MAS) | measures spasticity in patients with lesions to the central nervous system. MAS is an assessment that is used to measure the increase in muscle tone | Starting 4 weeks after consent, 3 times every 2 weeks for up to 22 weeks | 
| Manual Muscle Testing (MMT) | standardized set of assessments that measure muscle strength and function | Starting 4 weeks after consent, 3 times every 2 weeks for up to 22 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Capabilities of Upper Extremity Test (CUE-T) | A performance measure intended to assess upper extremity function following spinal cord injury (SCI) | Once at 2 weeks after consent, and once within 9-24 weeks after consent | 
| PROMIS Pain Interference- Adult Short Form 8a (PROMIS-PI) | A patient self-reported measure of consequences of pain on aspects of their life | Once at 2 weeks after consent, and once within 9-24 weeks after consent | 
| Walking Index for SCI (WISCI-II) | A measure of physical assistance needed, as well as devices required, for walking following paralysis that results from SCI | Once at 2 weeks after consent, and once within 9-24 weeks after consent | 
| Numeric Pain Rating Scale (NPRS) | The patient reported outcome measure the subjective intensity of pain | Once at 2 weeks after consent, and once within 9-24 weeks after consent | 
| Patient Global Impression of Change (PGIC) Questionnaires (bowel program, bladder function, dysreflexia, pain, sensation) | Questionnaires to assess the status of or changes in bladder function, bowel regimen, dysreflexia, pain and sensation. | Once at 2 weeks after consent, and once within 9-24 weeks after consent | 

 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, Transcutaneous Magnetic Simulation, Transcranial Magnetic Stimulation