Efficacy of a Wearable Noninvasive Neuromodulation Device (NCT07171489) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
See this in plain English?
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The Neurogenic Bowel Dysfunction (NBD) score
Timeframe: Baseline (phase-in) to 4-week visit
2
Prolonged colonic transit measurement to assess NBD severity
Timeframe: Baseline and approximately the 4-week post treatment visit