Vibrant Capsule for Spinal Cord Injury Neurogenic Bowel Dysfunction

Last updated: January 12, 2026
Sponsor: The University of Texas Health Science Center, Houston
Overall Status: Active - Recruiting

Phase

N/A

Condition

Constipation

Spinal Cord Injuries

Spinal Cord Disorders

Treatment

Vibrant Capsule

Clinical Study ID

NCT07213986
HSC-MS-25-0364
Project# 0019646
  • Ages > 21
  • All Genders

Study 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 Criteria

Inclusion

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 thescheduled bowel program.

  • Use of oral medications as part of the bowel program.

Exclusion

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 directcurrent magnetic field.

Study Design

Total Participants: 12
Treatment Group(s): 1
Primary Treatment: Vibrant Capsule
Phase:
Study Start date:
January 06, 2026
Estimated Completion Date:
March 01, 2026

Study 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 safety of the Vibrant capsule. This Vibrant capsule has been approved by the Food and Drug Administration (FDA) for chronic idiopathic constipation.

Connect with a study center

  • TIRR Memorial Hermann

    Houston 4699066, Texas 4736286 77030
    United States

    Active - Recruiting

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