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Vibrant Capsule for Spinal Cord Injury Neurogenic Bowel Dysfunction

This study is testing the Vibrant capsule for people with neurogenic bowel dysfunction (bowel problems caused by nerve damage) due to a spinal cord injury. The Vibrant capsule is a device you swallow that gently vibrates to help with chronic constipation. Researchers want to see if it's safe and effective for this condition. You might be able to join if you're an adult with a chronic spinal cord injury for over a year, have stable neurological function, and a consistent bowel program. The study will look at how many participants experience side effects to determine safety. The current status of the study is unclear.

Study design
This is an interventional study planning to enroll 12 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Safety will be measured at baseline for four weeks, and then for four weeks during treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07213986

Vibrant Capsule for Spinal Cord Injury Neurogenic Bowel Dysfunction

Recruiting
NAAges 21+InterventionalTreatment
The University of Texas Health Science Center, Houston
~12 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:Vibrant Capsule

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety of Vibrant capsule as indicated by number of participants who had an adverse event
Measured over baseline week 1, baseline week 2, baseline week 3, baseline week 4
+7 more outcomes measured

Conditions

Neurogenic Bowel Dysfunction
Spinal Cord Injury

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Neurogenic bladder dysfunctionSpinal Cord Injury

Where it's being run

1 sites across 1 states
Texas1

Study leadership

  • Argyrios Stampas, MD · PRINCIPAL_INVESTIGATOR · The University of Texas Health Science Center, Houston

Who to contact

Argyrios Stampas, MD
[email protected]
7127975938
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Safety of Vibrant capsule as indicated by number of participants who had an adverse eventbaseline 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 eventweek 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)baseline week 1, baseline week 2, baseline week 3, baseline week 4

    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 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, week 5 with treatment, week 6 with treatment, week 7 with treatment, week 8 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 Scorebaseline week 1, baseline week 2, baseline week 3, baseline week 4

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

  • Safety as assessed by average weekly Numerical Pain Scoreweek 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

    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)baseline, week 3

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

  • Safety as assessed by the Neurogenic Bladder Symptom Score (NBSS)week 1 with treatment, week 4 with treatment, week 8 with treatment

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