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Efficacy of a Wearable Noninvasive Neuromodulation Device

RecruitingNAAges 18 Years - anyAllUniversity of Michigan
NCT07171489 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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)
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What it tests

  • TNM at a sham-point (AccelBand) - randomized arm
  • TNM at a leg point (AccelBand)- randomized arm
  • TNM at a leg point (AccelBand)- open-label
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Where

1 site
University of Michigan
Ann Arbor, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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