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

Not Applicable

Not yet recruiting

• Conditions: Tetraplegia
• Interventions: Behavioral: transcutaneous Spinal Cord Stimulation (tSCS)

• Registration Number: NCT06140706
• Lead Sponsor: VA Palo Alto Health Care System

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-11-08
• Study First Submitted QC: 2023-11-14
• Study First Posted: 2023-11-20
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-07
• Last Update Posted: 2025-04-10
• Study Start: 2025-09-01
• Primary Completion: 2027-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Veteran
2. Age 18-65
3. All gender, any ethnicity
4. Cervical Spinal Cord Injury C2-8
5. American Spinal Injury Association (ASIA) Impairment Scale (AIS) B, C or D
6. GRASSP-Prehension Score >10 or GRASSP Strength Score >30
7. Greater than 1 year post injury
8. Able to identify a companion to assist with neurostimulator setup in home environment.
9. Internet connection to support video telehealth connection
10. Willingness to travel to the VA Palo Alto Medical Center

Exclusion Criteria

1. Cardiopulmonary disease or cardiac symptoms,
2. Autonomic dysreflexia that is uncontrolled or severe,
3. Implanted medical device(s),
4. Uncontrolled spasms that could limit participation in exercise training,
5. Skin breakdown or active pressure injury in areas of electrode placement.
6. Participants must not be engaged in any concurrent drug or device trial
7. Pregnant, are planning to become pregnant, or breastfeeding
8. The study is not deemed safe or appropriate in the opinion of the investigators

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
tSCS plus home tele-video support	transcutaneous Spinal Cord Stimulation (tSCS)	Cervical transcutaneous spinal stimulation during home tele-video visits

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

VA Palo Alto Health Care System; 🇺🇸 Palo Alto, California, United States