Vibrant Capsule for Spinal Cord Injury

Overseen By Argyrios Stampas, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas Health Science Center, Houston

Must be taking: Oral bowel medications

Disqualifiers: Bowel incontinence, Gastrointestinal disorders, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

12 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Vibrant capsules to determine their safety and effectiveness for individuals with spinal cord injuries who experience bowel movement difficulties. The focus is on assisting those with neurogenic bowel, where nerves do not properly control the bowels. It suits individuals who have had a spinal cord injury for over a year and follow a regular bowel program. Participants should have at least one scheduled bowel movement every three days using aids like suppositories or enemas. This trial offers a chance to explore a new treatment option if these criteria match the participant's situation. As an unphased trial, it provides a unique opportunity to contribute to early-stage research and potentially benefit from an innovative treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that participants should have a consistent bowel program, including oral medications, for at least three months before joining. It seems like you can continue your current bowel-related medications.

Is there any evidence suggesting that the Vibrant Capsule is likely to be safe for humans?

Research has shown that Vibrant Capsules have undergone testing to ensure safety and ease of use. In earlier studies involving individuals with chronic idiopathic constipation (CIC), the capsules were safe, and most participants did not experience major problems or side effects. The current study focuses on patients with spinal cord injuries who have bowel issues. The safety results from previous studies are encouraging. However, since this is a new application for the capsules, participants must report any problems experienced during the trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for spinal cord injury, which often involve surgery, physical therapy, and medications to manage symptoms, the Vibrant Capsule offers a novel approach. The unique feature of the Vibrant Capsule is its innovative delivery method, which is designed to be taken orally and potentially target the spinal cord directly through a new mechanism of action. Researchers are excited about this treatment because it could provide a less invasive option with the potential for enhanced precision in targeting spinal cord injuries, possibly leading to improved outcomes for patients.

What evidence suggests that the Vibrant Capsule is effective for neurogenic bowel in spinal cord injury patients?

Research shows that the Vibrant capsule, which participants in this trial will receive, may improve bowel function for people with spinal cord injuries. It gently vibrates in the intestines to stimulate bowel movements. In studies with individuals experiencing long-term constipation, 85% found the capsule easy to use and effective. This suggests it could also benefit those with bowel issues due to spinal cord injuries. Previous research has found the capsule to be safe and well-tolerated. ^{1 4 5 6 7}

Who Is on the Research Team?

Argyrios Stampas, MD

Principal Investigator

The University of Texas Health Science Center, Houston

Are You a Good Fit for This Trial?

This trial is for adults over 18 with chronic spinal cord injury (SCI) for more than a year, who have stable SCI conditions and follow a regular bowel program. It's not for non-English speakers, pregnant individuals, those with significant GI disorders, implanted devices affected by magnets, recent bowel issues or surgeries (except appendix removal), or certain esophageal conditions.

Inclusion Criteria

At least one scheduled bowel movement (BM) every three days

I am over 18 and have had a spinal cord injury for more than a year.

My spinal cord injury has been stable for at least 6 months.

Exclusion Criteria

Non-English-speaking individuals

History of significant gastrointestinal disorders

Pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Vibrant capsule to assess safety and effectiveness for 4 weeks

4 weeks

Weekly visits for assessment

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Vibrant Capsule

Trial Overview The Vibrant capsule is being tested to see if it's safe and effective in managing neurogenic bowel dysfunction in patients with spinal cord injuries. The study will involve participants using the capsule as part of their scheduled bowel management routine.

How Is the Trial Designed?

Group I: Vibrant Capsule Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas Health Science Center, Houston

Lead Sponsor

Trials

974

Recruited

361,000+

Mission Connect

Collaborator

Trials

1

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07213986

Vibrant Capsule for Spinal Cord Injury Neurogenic Bowel ... 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) ...

2. scitrialsfinder.net scitrialsfinder.net/trials/NCT07213986

Vibrant Capsule for Spinal Cord Injury Neurogenic Bowe The goal of this study is to test the safety and effectiveness of Vibrant capsules in spinal cord injury patients with neurogenic bowel.

3. withpower.com withpower.com/trial/phase-spinal-cord-injuries-10-2025-56dae

Vibrant Capsule for Spinal Cord Injury This trial is for adults over 18 with chronic spinal cord injury (SCI) for more than a year, who have stable SCI conditions and follow a regular bowel program.

4. healio.com healio.com/news/gastroenterology/20221118/vibrating-capsule-safe-well-tolerated-easy-to-use-in-chronic-idiopathic-constipation

Vibrating capsule safe, well tolerated, easy to use in ... After several months of treatment, 85% reported the system would be easy to use when commercialized. “The [vibrating capsule] is both safe and ...

5. centerwatch.com centerwatch.com/clinical-trials/listings/NCT07213986/vibrant-capsule-for-spinal-cord-injury-neurogenic-bowel-dysfunction?activelyRecruiting=false&page=126&id=247&slug=constipation

Vibrant Capsule for Spinal Cord Injury Neurogenic Bowel ... The goal of this study is to test the safety and effectiveness of Vibrant capsules in spinal cord injury patients with neurogenic bowel.

6. ctv.veeva.com ctv.veeva.com/study/vibrant-capsule-for-spinal-cord-injury-neurogenic-bowel-dysfunction

Vibrant Capsule for Spinal Cord Injury Neurogenic Bowel ... The goal of this study is to test the safety and effectiveness of Vibrant capsules in spinal cord injury patients with neurogenic bowel.

7. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40059867/

The Vibrating Capsule: Safety and Tolerability in Patients ... The Vibrating Capsule, a first in class treatment for CIC was found to be safe and well tolerated by patients in clinical trials.