Vibrant Capsule for Spinal Cord Injury Neurogenic Bowel Dysfunction

The University of Texas System (UT)

Status: Enrolling

Conditions: Neurogenic Bowel Dysfunction; Spinal Cord Injury

Treatments: Device: Vibrant Capsule

Study type: Interventional

Funder types: Other

Identifiers

NCT07213986

HSC-MS-25-0364

Project# 0019646 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 12 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

12 participants in 1 patient group

Vibrant Capsule

Experimental group

Treatment:

Device: Vibrant Capsule