Efficacy of a Wearable Noninvasive Neuromodulation Device

Technology
General health
Online since 19 December 2025, updated 4 days ago

About this trial

This trial is enrolling 100 participants with chronic spinal cord injury to test the effect of a wearable transcutaneous neuromodulation (TNM) device on bowel health. TNM is a non-invasive electrical stimulation technique that delivers low-level current through surface electrodes on the skin to modulate nerve activity and influence organ or muscle function. If included, participants will be randomly assigned to self-administer either active or sham TNM twice daily for 4 weeks. Participants in the sham group may opt into an additional 2-week active TNM phase. Final testing of bowel function will be performed after 4 weeks.

Included participants

Gender
All
Age
≥ 18 years
Injury level
C1 - T11
  • Severity (AIS)?
  • AIS-B
    AIS-C
    AIS-D
    Time since injury
    ≥ 6 months
  • Injury type
  • Traumatic

    Non-traumatic

    Healthy volunteers
    No
    C1-T11
    Additionally, participants must
    NOT have implanted medical devices for electrical stimulation (e.g. cardiac pacemaker)

    What’s involved

    Type

    Technology

    Details

    - Participants will be randomly assigned to self-administer either active or sham transcutaneous neuromodulation (TNM) twice daily for 4 weeks. - TNM is a non-invasive electrical stimulation technique that delivers low-level current through surface electrodes on the skin to modulate nerve activity and influence organ or muscle function. - After unblinding, participants in the sham group may opt into an additional 2-week active TNM phase. - Final testing of bowel function will be performed after 4 weeks.

    Potential benefits

    Main benefits

    General health

    Additional benefits

    Bowel health

    Mental health and psychosocial factors

    Sensory function

    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 Nov 2025
    • Organisation
    • University of Michigan
    • Trial recruitment status
    • Recruiting soon
    • Trial start date
    • 1 Nov 2025
    • Organisation
    • University of Michigan

    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