Vibrant Capsule for Spinal Cord Injury Neurogenic Bowel Dysfunction

Not Applicable

Recruiting

• Conditions: Neurogenic Bowel Dysfunction; Spinal Cord Injury

• Registration Number: NCT07213986
• Lead Sponsor: The University of Texas Health Science Center, Houston

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

Study Timeline

• Status Verified: 2025-10
• Study First Submitted: 2025-10-06
• Study First Submitted QC: 2025-10-06
• Last Update Submitted: 2025-10-06
• Study First Posted: 2025-10-09
• Last Update Posted: 2025-10-09
• Study Start: 2025-11-01
• Primary Completion: 2026-03-01
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 12

Inclusion Criteria

• Individuals aged 18 years and older 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Safety of Vibrant capsule as indicated by number of participants who had an adverse event	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)	week 1 with treatment, week 2 with treatment, week 3 with treatment, week 4 with treatment	The total score on the Penn Spasm Frequency Scale (PSFS) ranges from 0 to 7, and a higher score indicates greater spasm frequency and severity.
Safety as assessed by average weekly Numerical Pain Score	week 1 with treatment, week 2 with treatment, week 3 with treatment, week 4 with treatment	The Numerical Pain Score ranges from 0 to 10, with a higher score indicating greater pain.
Safety as assessed by the Neurogenic Bladder Symptom Score (NBSS)	week 1 with treatment, week 4 with treatment	The Neurogenic Bladder Symptom Score (NBSS) ranges from 0 to 96, with a higher score indicating greater Neurogenic Bladder Symptoms.

Secondary Outcome Measures

Name	Time	Method
Feasibility of using the Vibrant capsule as indicated by adherence	from week 1 with treatment to week 4 with treatment	Feasibility of the Vibrant capsule will be recorded in this patient population by adherence to the protocol.
Feasibility of using the Vibrant capsule as indicated by a satisfaction survey	end of study (4 weeks after start of treatment)	Feasibility will also be recorded by a satisfaction survey completed by the study participant. Total score ranges from 0 to 40, with a higher score indicating higher satisfaction.

Trial Locations

Locations (1)

TIRR Memorial Hermann; 🇺🇸 Houston, Texas, United States