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

Technology
Standing/walking/mobility
Online since 20 November 2023, updated 92 days ago

About this trial

This trial is enrolling 10 individuals with chronic spinal cord injuries (12 months or longer) to test the effect of non-invasive electrical and magnetic neuromodulation on mobility. Neuromodulation is the alteration of nerve activity through the targeted delivery of a stimulus. If included, participants will receive closed-loop skin-surface (transcutaneous) spinal cord stimulation via the RISES-T System (stimulation device, wearable sensors, and recording software) while completing repetitive task practice. Participants will also undergo a series of targeted tasks with and without electromagnetic stimulation. Final testing for movement recovery will be performed after 24 weeks.

Included participants

Gender
All
Age
≥ 18 years
Injury level
C1 - S5
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    ≥ 12 months
    Healthy volunteers
    No
    C1-S5
    Additionally, participants must
    NOT have uncontrolled cardiopulmonary disease or cardiac symptoms
    NOT require ventilator support
    NOT have any active implanted medical device

    What’s involved

    Type

    Technology

    Details

    - Participants will receive closed-loop transcutaneous spinal cord stimulation while completing repetitive task practice. - Part 1 of the trial aims to determine which of the participant's muscles respond to stimulation and what stimulation parameters would be best suited for the participant. - During Part 2 of the trial, participants will receive transcutaneous stimulation to the target muscles identified in Part 1, using the parameters deemed best suited for the participant. - The participant will continue in the study for a maximum of 6 stimulation cycles or until there is no observed effect of stimulation for 3 consecutive cycles. - Final testing will be performed after 24 weeks.

    Potential benefits

    Main benefits

    Standing/walking/mobility

    Additional benefits

    Arm/hand function

    Pain

    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
    • By invitation
    • Trial start date
    • 23 Jun 2023
    • Organisation
    • Thomas Jefferson University
    • Trial recruitment status
    • By invitation
    • Trial start date
    • 23 Jun 2023
    • Organisation
    • Thomas Jefferson University

    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