RecruitingNot Applicable

Vibrant Capsule for Spinal Cord Injury Neurogenic Bowel Dysfunction

United States12 participantsStarted 2026-01-06

Plain-language summary

The goal of this study is to test the safety and effectiveness of Vibrant capsules in spinal cord injury patients with neurogenic bowel.

Who can participate

Age range

21 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: * Individuals with chronic spinal cord injury (SCI) of more than one year. * Stable neurological level and function of SCI for at least six months. * Consistent bowel program without changes for at least 3 months. * At least one scheduled bowel movement (BM) every three days. * Use of digital stimulation, suppositories, enemas, or mini enemas, as part of the scheduled bowel program. * Use of oral medications as part of the bowel program. Exclusion Criteria: * Bowel incontinence occurring more than once per week. * Non-English-speaking individuals. * History of bowel obstruction, ileus, diverticulitis, or bowel surgery for a disease (appendix removal is ok). * Persistent autonomic dysreflexia (AD) triggered by bowel movements. * Recent changes to spasticity medications within the past month. * History of significant gastrointestinal disorders * History of Zenker's diverticulum * Dysphagia * Esophageal stricture * Eosinophilic esophagitis or achalasia * Pregnancy. * Presence of implanted devices that could be affected by proximity to a direct current magnetic field.

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

Safety of Vibrant capsule as indicated by number of participants who had an adverse event

Timeframe: baseline week 1, baseline week 2, baseline week 3, baseline week 4

Safety of Vibrant capsule as indicated by number of participants who had an adverse event

Timeframe: week 1 with treatment, week 2 with treatment, week 3 with treatment, week 4 with treatment

Safety of Vibrant capsule as assessed by the Penn Spasm Frequency Scale (PSFS)

Timeframe: baseline week 1, baseline week 2, baseline week 3, baseline week 4

Safety of Vibrant capsule as assessed by the Penn Spasm Frequency Scale (PSFS)

Timeframe: week 1 with treatment, week 2 with treatment, week 3 with treatment, week 4 with treatment

Safety as assessed by average weekly Numerical Pain Score

Timeframe: baseline week 1, baseline week 2, baseline week 3, baseline week 4

Safety as assessed by average weekly Numerical Pain Score

Timeframe: week 1 with treatment, week 2 with treatment, week 3 with treatment, week 4 with treatment

Trial details

NCT IDNCT07213986

SponsorThe University of Texas Health Science Center, Houston

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08-19

Contact for this trial

Argyrios Stampas, MD

7127975938 argyrios.stampas@uth.tmc.edu

View on ClinicalTrials.gov More Neurogenic Bowel Dysfunction trials