Status:
NOT_YET_RECRUITING
Efficacy of a Wearable Noninvasive Neuromodulation Device
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Conditions:
Spinal Cord Injuries
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 w...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2029
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07171489
Start Date
November 1 2025
End Date
November 1 2029
Last Update
September 12 2025
Active Locations (1)
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1
University of Michigan
Ann Arbor, Michigan, United States, 48109