NCT07171489NARecruiting

Efficacy of a Wearable Noninvasive Neuromodulation Device

University of Michigan

Start Date

7/1/2026

Completion Date

11/1/2029

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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)

Interventions

DEVICE

TNM at a sham-point (AccelBand) - randomized arm

DEVICE

TNM at a leg point (AccelBand)- randomized arm

DEVICE

TNM at a leg point (AccelBand)- open-label

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Conditions

Spinal Cord Injuries

Locations

University of Michigan

Ann Arbor, Michigan 48109

United States