NCT07213986 · The University of Texas Health Science Center, Houston
Vibrant Capsule for Spinal Cord Injury Neurogenic Bowel Dysfunction
What this study is about
The goal of this study is to test the safety and effectiveness of Vibrant capsules in spinal cord injury patients with neurogenic bowel.
View original scientific description
The goal of this study is to test the safety and effectiveness of Vibrant capsules in spinal cord injury patients with neurogenic bowel.
Interventions
DEVICE
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 measures
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
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)
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
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 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.
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
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)
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.
Safety as assessed by the Neurogenic Bladder Symptom Score (NBSS)
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Esophageal stricture
- Eosinophilic esophagitis or achalasia
- Presence of implanted devices that could be affected by proximity to a direct current magnetic field.
Where
- Houston, Texas
Collaborators
Mission Connect
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 21, 2026 · Source of record for eligibility and locations