NCT06140706

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: VA Palo Alto Health Care System · Federal
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Tetraplegia

Interventions

Type	Name	Description
BEHAVIORAL	transcutaneous Spinal Cord Stimulation (tSCS)	Neurostimulation for upper extremity training, delivered through video telehealth, 8 weeks of home use for (i) feasibility and (ii) potential functional improvement.

Timeline

• Start date: 2025-09-01
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2023-11-20
• Last updated: 2025-04-10

Locations

1 site across 1 country: United States