Wearable neuromodulation to help bowel symptoms after spinal cord injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study examines whether a wearable transcutaneous neuromodulation device can reduce constipation symptoms linked to neurogenic bowel dysfunction in individuals with spinal cord injury. Participants are randomized to receive TNM at a sham point, TNM at a leg point, or an open-label leg-point TNM, with outcomes comparing baseline to post-therapy. The device aims to improve autonomic function and bowel symptoms, using standardized questionnaires and anorectal testing to assess results. Eligible participants include adults with SCI above T12, with chronic SCI and documented NBD, who consent to participate. Exclusion criteria screen for cognitive impairment, major GI surgeries (beyond a few common procedures), diabetes, psychiatric illness, substance abuse, implanted electrical devices, opioid use, pregnancy, active inflammatory bowel disease, ventilator dependence, or severe autonomic dysreflexia.

Why it matters

Who can join: the full rules

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)

Where it's running

• University of Michigan
  Ann Arbor, Michigan, United States Recruiting

Study contacts

• Principal investigator: Gianna Rodriguez, MD — University of Michigan
• Study coordinator: Caitlyn Fisher
• Email: fishercj@med.umich.edu
• Phone: 734-998-7285

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.