Vibrant Capsule for Spinal Cord Injury Neurogenic Bowel Dysfunction

NCT07213986 | Recruiting FDA Device

• 2 other identifiers: HSC-MS-25-0364Project# 0019646
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurogenic Bowel Dysfunction; Spinal Cord Injury

Outcome Measures

Primary Outcomes (8)

• Safety of Vibrant capsule as indicated by number of participants who had an adverse event

  baseline week 1, baseline week 2, baseline week 3, baseline week 4

• 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)

  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.

  baseline week 1, baseline week 2, baseline week 3, baseline week 4

• Safety of Vibrant capsule as assessed by the Penn Spasm Frequency Scale (PSFS)

  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.

  week 1 with treatment, week 2 with treatment, week 3 with treatment, week 4 with treatment

• Safety as assessed by average weekly Numerical Pain Score

  The Numerical Pain Score ranges from 0 to 10, with a higher score indicating greater pain.

  baseline week 1, baseline week 2, baseline week 3, baseline week 4

• Safety as assessed by average weekly Numerical Pain Score

  The Numerical Pain Score ranges from 0 to 10, with a higher score indicating greater pain.

  week 1 with treatment, week 2 with treatment, week 3 with treatment, week 4 with treatment

• Safety as assessed by the Neurogenic Bladder Symptom Score (NBSS)

  The Neurogenic Bladder Symptom Score (NBSS) ranges from 0 to 96, with a higher score indicating greater Neurogenic Bladder Symptoms.

  baseline, week 3

• Safety as assessed by the Neurogenic Bladder Symptom Score (NBSS)

  The Neurogenic Bladder Symptom Score (NBSS) ranges from 0 to 96, with a higher score indicating greater Neurogenic Bladder Symptoms.

  week 1 with treatment, week 4 with treatment

Secondary Outcomes (2)

• Feasibility as indicated by the number of participants that adhere to the prescribed use of Vibrant

  from week 1 with treatment to week 4 with treatment

• Feasibility of using the Vibrant capsule as indicated by a satisfaction survey

  end of study (4 weeks after start of treatment)

Study Arms (1)

Vibrant Capsule

EXPERIMENTAL

Device: Vibrant Capsule

Interventions

Vibrant Capsule DEVICE

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.

Vibrant Capsule

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• Mission Connect: collaborator

Study Sites (1)

TIRR Memorial Hermann

Houston, Texas, 77030, United States

RECRUITING

Related Publications (4)

• American College of Gastroenterology Chronic Constipation Task Force. An evidence-based approach to the management of chronic constipation in North America. Am J Gastroenterol. 2005;100 Suppl 1:S1-4. doi: 10.1111/j.1572-0241.2005.50613_1.x. No abstract available.

  PMID: 16008640 BACKGROUND

• Rao SSC, Lembo A, Chey WD, Friedenberg K, Quigley EMM. Effects of the vibrating capsule on colonic circadian rhythm and bowel symptoms in chronic idiopathic constipation. Neurogastroenterol Motil. 2020 Nov;32(11):e13890. doi: 10.1111/nmo.13890. Epub 2020 May 25.

  PMID: 32449277 BACKGROUND

• Ron Y, Halpern Z, Safadi R, Dickman R, Dekel R, Sperber AD. Safety and efficacy of the vibrating capsule, an innovative non-pharmacological treatment modality for chronic constipation. Neurogastroenterol Motil. 2015 Jan;27(1):99-104. doi: 10.1111/nmo.12485. Epub 2014 Dec 6.

  PMID: 25484196 BACKGROUND

• Qi Z, Middleton JW, Malcolm A. Bowel Dysfunction in Spinal Cord Injury. Curr Gastroenterol Rep. 2018 Aug 29;20(10):47. doi: 10.1007/s11894-018-0655-4.

  PMID: 30159690 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Argyrios Stampas, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Argyrios Stampas, MD

CONTACT

7127975938; argyrios.stampas@uth.tmc.edu

Danira Garcia Gutierrez, BS

CONTACT

7137977133

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 6, 2025
• First Posted: October 9, 2025
• Study Start: January 6, 2026
• Primary Completion (Estimated): August 19, 2026
• Study Completion (Estimated): August 19, 2026
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)