Clinical Trial

Efficacy of a Wearable Noninvasive Neuromodulation Device

Recruiting
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Summary
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-09-05.
Status change: Not Yet Recruiting → Recruiting 2026-07-01
Trial Details
NCT Number NCT07171489
Lead Sponsor University of Michigan
Collaborators: National Institute of Neurological Disorders and Stroke (NINDS)
Conditions Spinal Cord Injuries
Enrollment 100 participants
Start Date 2026-07
Primary Completion 2029-11 (estimated)
Study Completion 2029-11 (estimated)
Updated on ClinicalTrials.gov 2026-07-06