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

Technology
Arm/hand function
Online since 18 December 2023, updated 74 days ago

About this trial

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 neurostimulato...

Included participants

Gender
All
Age
18 - 75 years
Injury level
C2 - C8
  • Severity (AIS)?
  • AIS-B
    AIS-C
    AIS-D
    Time since injury
    ≥ 1 year
    Healthy volunteers
    No
    C2-C8
    Additionally, participants must
    NOT have cardiopulmonary disease or cardiac symptoms
    NOT have implanted medical devices

    What’s involved

    Type

    Technology

    Details

    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.

    Potential benefits

    Main benefits

    Arm/hand function

    Additional benefits

    General health

    Good to know: Potential benefits are defined as outcomes that are being measured during and/or after the trial.

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more

    • Trial recruitment status
    • Recruiting soon
    • Trial start date
    • 1 Jan 2024
    • Organisation
    • VA Palo Alto Health Care System
    • Trial recruitment status
    • Recruiting soon
    • Trial start date
    • 1 Jan 2024
    • Organisation
    • VA Palo Alto Health Care System

    Wings for Life supports SCITrialsFinder

    Wings for Life has proudly initiated, led and funded the new version of the SCI Trials Finder website. Wings for Life aims to find a cure for spinal cord injuries. The not-for-profit foundation funds world-class scientific research and clinical trials around the globe.

    Learn more