Feasibility of Home Based Transcutaneous Spinal Cord Stimulation for Persons With SCI

Study Overview
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Brief Summary
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The proposed study will focus on the feasibility of and effectiveness to a home-based program for persons with chronic SCI focused on upper limb training augmented with a transcutaneous neurostimulator supported via a video telehealth platform.

Detailed Description
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The overarching goal of this study is to train participants with tetraplegia and their companion to operate a non-invasive surface applied neurostimulation unit (ONWARD, ARCex) while performing a prescriptive functional task based upper extremity home program for 2 months. Participants will be supported with video-telehealth to assist with any difficulties that may arise and to progress their upper extremity home program. Evaluations will assess the feasibility of this video telehealth supported model as measured by the ease of use of the technology (QUEST 2.0, NASA-TLX) as well as participants ability to attend and complete all the training visits. Changes in upper extremity physical function will be measured using validated clinical tools (GRASSP, CUE-Q, DASH, COPM) as well as detailed evaluation of upper extremity muscle activation from surface EMG and strength measurements of pinch and grasp. The primary outcome measure of this study is feasibility, and the secondary outcome measure is to capture changes in upper extremity performance.

Official Title
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Feasibility of a Video Telehealth Model to Evaluate Home Use of Transcutaneous Spinal Cord Stimulation for Enhanced Upper Limb Function

Conditions
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Tetraplegia

Intervention / Treatment
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* Behavioral: transcutaneous Spinal Cord Stimulation (tSCS)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Veteran Age 18-65 All gender, any ethnicity Cervical Spinal Cord Injury C2-8 American Spinal Injury Association (ASIA) Impairment Scale (AIS) B, C or D GRASSP-Prehension Score >10 or GRASSP Strength Score >30 Greater than 1 year post injury Able to identify a companion to assist with neurostimulator setup in home environment. Internet connection to support video telehealth connection Willingness to travel to the VA Palo Alto Medical Center Exclusion Criteria: Cardiopulmonary disease or cardiac symptoms, Autonomic dysreflexia that is uncontrolled or severe, Implanted medical device(s), Uncontrolled spasms that could limit participation in exercise training, Skin breakdown or active pressure injury in areas of electrode placement. Participants must not be engaged in any concurrent drug or device trial Pregnant, are planning to become pregnant, or breastfeeding The study is not deemed safe or appropriate in the opinion of the investigators

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: tSCS plus home tele-video support<br>Cervical transcutaneous spinal stimulation during home tele-video visits | Behavioral: transcutaneous Spinal Cord Stimulation (tSCS)<br>* Neurostimulation for upper extremity training, delivered through video telehealth, 8 weeks of home use for (i) feasibility and (ii) potential functional improvement.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NASA-TLX (NASA Task Load Index) | Measures subjective mental work load & physical effort | At 8 weeks (after completion of home program) | 
| QUEST 2.0 (Quebec User Evaluation of Satisfaction with assistive Technology) | Measures usability of device (eg, adjustability, comfort, safety and effectiveness) | At 8 weeks (after completion of home program) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GRASSP (The Graded Redefined Assessment of Strength Sensibility and Prehension) | Measures upper limb sensation, strength, and prehension | At entry (Baseline) and repeated at 8 weeks (after completion of home program) | 
| CUE-Q (Capabilities of Upper Extremity Function) | Measures functional limitation and difficulty in performing upper limb activities | At entry (Baseline) and repeated at 8 weeks (after completion of home program) | 
| DASH (Disabilities of the Arm, Shoulder, and Hand) | Measures upper limb function during ADL tasks, work activities, recreational sports, and pain-related limitations | At entry (Baseline) and repeated at 8 weeks (after completion of home program) | 
| COPM (Canadian Occupational Performance Measure) | Measures performance & satisfaction of self-identified activities in self-care, productivity and leisure | At entry (Baseline) and repeated at 8 weeks (after completion of home program) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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paralysis, exercise, telemedicine, spinal cord stimulation, physical activity