Transdermal Administration by a Novel Wireless Iontophoresis Device

Drug
Bowel health
Online since 7 October 2024, updated 225 days ago

About this trial

This pilot study is enrolling 6 individuals with spinal cord injury to test the effect of a novel skin-surface device to deliver neostigmine and glycopyrrolate to improve bowel evacuation. This device allows for the medications to be administered through the skin and into the blood by applying an undetectable electrical current (a process called iontophoresis) rather than using needle injections. If included, participants will receive the 2 medications (neostigmine and glycopyrrolate) transdermally using the wireless ION device during 3 separate sessions. Final testing of bowel health will be performed after 3 days.

Included participants

Gender
All
Age
18 - 89 years
Injury level
C1 - S5
  • Severity (AIS)?
  • Time since injury
    All
    Healthy volunteers
    Yes
    C1-S5
    Additionally, participants must
    NOT have a deep brain stimulation device
    NOT have a history of bowel or bladder obstruction
    NOT have a history of heart conditions including coronary artery disease, myocardial infarctions, or arrhythmias

    What’s involved

    Type

    Drug

    Details

    - Participants will receive 2 medications (neostigmine and glycopyrrolate) transdermally using the wireless ION device in 3 separate sessions. - This allows for the medication to be administered through the skin and into the circulation of the body by applying an undetectable electrical current rather than intravenously or intramuscularly. - Final testing of bowel evacuation will be performed after 3 days.

    Potential benefits

    Main benefits

    Bowel health

    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
    • Trial start date
    • 22 Mar 2022
    • Organisation
    • James J. Peters Veterans Affairs Medical Center
    • Trial recruitment status
    • Recruiting
    • Trial start date
    • 22 Mar 2022
    • Organisation
    • James J. Peters Veterans Affairs Medical Center

    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