Efficacy of a Wearable Noninvasive Neuromodulation Device (NCT07171489)
🩺 Plain-English Summary (8th-Grade Level)
The aim of this study is to investigate the potential of transcutaneous neuromodulation (TNM) to treat slow colonic transit and constipation, termed the Neurogenic bowel dysfunction (NBD), in people with SCI. In this project, the study team will investigate the impact of an active treatment intervention vs. a sham control intervention on NBD symptoms in patients with SCI. The study hypotheses: * The proposed TNM treatment at a leg point will reduce NBD symptoms between baseline and post-therapy, when compared to the sham-TNM treatment. * The therapeutic effect of TNM to improve the NBD symptoms is associated with improvement of the autonomic function in SCI patients.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (6 items) and avoid the listed exclusions (14 items).
Location: University of Michigan — Ann Arbor, Michigan
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- Exclusion Criteria:
- Significant cognitive impairment, impeding the ability to provide informed consent or complete the questionnaire
- Prior gastrointestinal surgeries other than uncomplicated appendectomies, cholecystectomy or cesarean sections
- Known diagnosis of diabetes mellitus
- Known current or past severe significant psychiatric disorder
- Known current substance abuse
- Implanted medical devices for electrical stimulation (e.g. cardiac pacemaker)
- Taking opioid medications on a regular daily basis
- Currently pregnant or actively planning a pregnancy
- Active inflammatory bowel disease
- Ventilator dependency
- Severe autonomic dysreflexia
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (1 Sites)
- University of Michigan — Ann Arbor, Michigan
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.