RecruitingNot ApplicableNCT07213986

Vibrant Capsule for Spinal Cord Injury Neurogenic Bowel Dysfunction

Pilot Trial of the Vibrant Capsule for Spinal Cord Injury Neurogenic Bowel Dysfunction

Sponsor

The University of Texas Health Science Center, Houston

Enrollment

12 participants

Start Date

Jan 6, 2026

Study Type

INTERVENTIONAL

Conditions

Spinal Cord Injury neurogenic bowel dysfunction

Summary

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

Eligibility

Min Age: 21 Years

Inclusion Criteria6

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 Criteria12

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.

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Interventions

DEVICEVibrant Capsule

The Vibrant capsule is designed to alleviate chronic constipation by stimulating the colon through gentle vibrations. The Vibrant capsule will be swallowed and tracked through the digestive system of spinal cord injury patients.