Recruiting

Vibrant

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT07213986

Conditions

Neurogenic Bowel Dysfunction

Spinal Cord Injury

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

Interventions

Vibrant Capsule

Study Details

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

Study ID

NCT07213986

Start date

Jan 6, 2026

Status verified date

Aug, 2026

Completion date

Aug 19, 2026

Anticipated

Primary completion date

Aug 19, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

12 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Vibrant Capsule

Interventions

Vibrant 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.

Primary outcome measure

  • Safety of Vibrant capsule as indicated by number of participants who had an adverse event [ Time Frame: 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 [ Time Frame: week 1 with treatment, week 2 with treatment, week 3 with treatment, week 4 with treatment, week 5 with treatment, week 6 with treatment, week 7 with treatment, week 8 with treatment ]
  • Safety of Vibrant capsule as assessed by the Penn Spasm Frequency Scale (PSFS) [ Time Frame: 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) [ Time Frame: week 1 with treatment, week 2 with treatment, week 3 with treatment, week 4 with treatment, week 5 with treatment, week 6 with treatment, week 7 with treatment, week 8 with treatment ]
  • Safety as assessed by average weekly Numerical Pain Score [ Time Frame: baseline week 1, baseline week 2, baseline week 3, baseline week 4 ]
  • Safety as assessed by average weekly Numerical Pain Score [ Time Frame: week 1 with treatment, week 2 with treatment, week 3 with treatment, week 4 with treatment, week 5 with treatment, week 6 with treatment, week 7 with treatment, week 8 with treatment ]
  • Safety as assessed by the Neurogenic Bladder Symptom Score (NBSS) [ Time Frame: baseline, week 3 ]
  • Safety as assessed by the Neurogenic Bladder Symptom Score (NBSS) [ Time Frame: week 1 with treatment, week 4 with treatment, week 8 with treatment ]

Central Contacts and Locations

Central contacts

Argyrios Stampas, MD

7127975938argyrios.stampas@uth.tmc.edu

Danira Garcia Gutierrez, BS

7137977133

Locations

TIRR Memorial Hermann

Recruiting

Houston, Texas, United States, 77030

Contacts

Danira Garcia Gutierrez, BS

713-797-7133Danira.GarciaGutierrez@uth.tmc.edu

Jacqueline B Martinez, BS

7137975765Jacqueline.b.martinez@uth.tmc.edu

Principal Investigator:

Argyrios Stampas, MD

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2026-08-21.