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NCT Number: NCT07213986

Vibrant Capsule for Spinal Cord Injury Neurogenic Bowel Dysfunction

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

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Key information

Conditions

Neurogenic Bowel Dysfunction Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Spinal Cord Injury Trauma, Nervous System Wounds and Injuries

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  2. 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

  3. 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

    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.

  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

    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.

  5. Safety as assessed by average weekly Numerical Pain Score

    Time frame: baseline 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.

  6. 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

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

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

    Time frame: baseline, week 3

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

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

    Time frame: 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 outcomes

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

    Time frame: 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.

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

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Argyrios Stampas, MD

CONTACT

[email protected]

7127975938

Danira Garcia Gutierrez, BS

CONTACT

7137977133

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • Mission Connect

Registry information

Official study title

Pilot Trial of the Vibrant Capsule for Spinal Cord Injury Neurogenic Bowel Dysfunction

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Oct 9, 2025
Registry last updated
May 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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