Not Yet RecruitingNot Applicable

Efficacy of a Wearable Noninvasive Neuromodulation Device

United States100 participantsStarted 2025-11

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Traumatic or non-traumatic spinal cord injury (SCI) * SCI level above the twelfth thoracic vertebra (T12) * SCI classified as Sensory Incomplete (AIS B), C, or D * Post-SCI time ≥ 6 months; * Neurogenic bowel dysfunction (NBD) as a result of SCI * Willing to sign the informed consent form 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 * No preservation of the sacral spinal reflexes: bulbocavernosus, patella, or Achilles * Complete absence of sensation in the leg (since it is needed for calibrating the TNM intensity)

What they're measuring

The Neurogenic Bowel Dysfunction (NBD) score

Timeframe: Baseline (phase-in) to 4-week visit

Prolonged colonic transit measurement to assess NBD severity

Timeframe: Baseline and approximately the 4-week post treatment visit

Trial details

NCT IDNCT07171489

SponsorUniversity of Michigan

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-11

Contact for this trial

Caitlyn Fisher

734-998-7285 fishercj@med.umich.edu