Avation Electric Stimulation System for Spinal Cord Injury Neurogenic Bladder

Technology
Bladder health/function
Online since 15 March 2025, updated 4 days ago

About this trial

This trial is enrolling 20 participants with chronic spinal cord injury to test the effect of tibial nerve stimulation (TNS) on bladder function. TNS is a technique for stimulating the tibial nerve via surface stimulation to modify spinal cord function. If included, participants will undergo stimulation with the Vivally system (a wearable, non-invasive neuromodulation device worn on the ankle) at 4 daily time points in the first month. They will then use the system for an additional 2 months with optimized stimulation parameters. Final testing of feasibility and bladder function will be performed after 12 weeks.

Included participants

Gender
All
Age
18 - 75 years
Injury level
C1 - T10
  • Severity (AIS)?
  • Time since injury
    ≥ 6 months
    Healthy volunteers
    No
    C1-T10

    What’s involved

    Type

    Technology

    Details

    - Participants will undergo tibial nerve stimulation (TNS) at 4 daily time points in the first month: 1) supine while in bed, 2) seated in the morning, 3) sitting in the afternoon, and 4) sitting in the evening. - They will then use the system for an additional 2 months with optimized stimulation parameters. - TNS is a technique for stimulating the tibial nerve via surface stimulation to modify spinal cord function. - Final testing of feasibility and bladder function will be performed after 12 weeks.

    Potential benefits

    Main benefits

    Bladder health/function

    Additional benefits

    Bowel health

    General health

    Mental health and psychosocial factors

    Pain

    Spasticity

    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 Dec 2024
    • Organisation
    • The University of Texas Health Science Center, Houston
    • Trial recruitment status
    • Recruiting soon
    • Trial start date
    • 1 Dec 2024
    • Organisation
    • The University of Texas Health Science Center, Houston

    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