Status:
RECRUITING
Vibrant Capsule for Spinal Cord Injury Neurogenic Bowel Dysfunction
Lead Sponsor:
The University of Texas Health Science Center, Houston
Collaborating Sponsors:
Mission Connect
Conditions:
Neurogenic Bowel Dysfunction
Spinal Cord Injury
Eligibility:
All Genders
21+ years
Phase:
NA
Brief Summary
The goal of this study is to test the safety and effectiveness of Vibrant capsules in spinal cord injury patients with neurogenic bowel.
Detailed Description
The purpose of this study is to see how well the Vibrant capsule works at treating people with spinal cord injury (SCI)-induced upper motor neuron (UMN) neurogenic bowel. This study will test the safe...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2026
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT07213986
Start Date
November 1 2025
End Date
March 1 2026
Last Update
October 27 2025
Active Locations (1)
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1
TIRR Memorial Hermann
Houston, Texas, United States, 77030