Spinal COrd NeuromodulaTor by SpIneX and ScoNE to Treat NeurogeniC BladdEr - SCONE "CONTINENCE" Clinical Study

Technology
Bladder health/function
Online since 12 March 2024, updated 66 days ago

About this trial

This trial is enrolling individuals with chronic cervical or thoracic spinal cord injuries to test the effect of skin-surface (transcutaneous) electrical stimulation of the spinal cord. Investigators want to see if a neuromodulation technique called SCONE (Spinal COrd NEuromodulation) improves urinary tract dysfunction. If included, participants will receive SCONE therapy for 12 weeks with either: 1) experimental neuromodulation; or 2) sham (inactive) neuromodulation. Final testing will be performed after 12 weeks.

Included participants

Gender
All
Age
18 - 70 years
Injury level
C3 - T8
  • Severity (AIS)?
  • AIS-A
    AIS-B
    AIS-C
    AIS-D
    Time since injury
    ≥ 1 year
    Healthy volunteers
    No
    C3-T8
    Additionally, participants must
    NO congestive heart failure
    NO other concurrent neurological disease
    NO implanted neuromodulator

    What’s involved

    Type

    Technology

    Details

    Participants will receive SCONE neuromodulation therapy for 12 weeks with either 1) experimental neuromodulation or 2) Sham neuromodulation. Final testing will be performed after 12 weeks.

    Potential benefits

    Main benefits

    Bladder health/function

    Additional benefits

    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
    • Trial start date
    • 25 May 2022
    • Organisation
    • SpineX Inc.
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 25 May 2022
    • Organisation
    • SpineX Inc.

    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