Neurogenic Bowel DysfunctionNCT07213986
Vibrant Capsule for Spinal Cord Injury Neurogenic Bowel Dysfunction
A study testing Vibrant Capsule in people with Neurogenic Bowel Dysfunction and Spinal Cord Injury, run by The University of Texas Health Science Center, Houston at 1 site in United States.
Trial summary
The goal of this study is to test the safety and effectiveness of Vibrant capsules in spinal cord injury patients with neurogenic bowel. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Neurogenic Bowel Dysfunction, Spinal Cord Injury
- What is being tested?
- Vibrant Capsule
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2026to 19 Aug 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Danira Garcia Gutierrez, BS contact
United States1 site, 1 recruiting
- Recruiting
TIRR Memorial Hermann
Houston, Texas, 77030
Danira Garcia Gutierrez, BS, 713-797-7133, Danira.GarciaGutierrez@uth.tmc.edu
Jacqueline B Martinez, BS, 7137975765, Jacqueline.b.martinez@uth.tmc.edu
About this study
Official title: Pilot Trial of the 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.
Read the detailed description
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.
- Conditions
- Neurogenic Bowel Dysfunction, Spinal Cord Injury
- Being tested
- Vibrant Capsule
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrant CapsuleDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Vibrant Capsule | Experimental | Not described Receives: Device: Vibrant Capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Vibrant capsule as indicated by number of participants who had an adverse event
Measured: 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
Measured: 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)
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.
Measured: 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)
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.
Measured: 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
The Numerical Pain Score ranges from 0 to 10, with a higher score indicating greater pain.
Measured: baseline week 1, baseline week 2, baseline week 3, baseline week 4
Safety as assessed by average weekly Numerical Pain Score
The Numerical Pain Score ranges from 0 to 10, with a higher score indicating greater pain.
Measured: 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)
The Neurogenic Bladder Symptom Score (NBSS) ranges from 0 to 96, with a higher score indicating greater Neurogenic Bladder Symptoms.
Measured: baseline, week 3
Safety as assessed by the Neurogenic Bladder Symptom Score (NBSS)
The Neurogenic Bladder Symptom Score (NBSS) ranges from 0 to 96, with a higher score indicating greater Neurogenic Bladder Symptoms.
Measured: week 1 with treatment, week 4 with treatment, week 8 with treatment
Secondary outcomes (2)
Feasibility as indicated by the number of participants that adhere to the prescribed use of Vibrant
Feasibility of the Vibrant capsule will be recorded in this patient population by adherence to the protocol.
Measured: from week 1 with treatment to week 8 with treatment
Feasibility of using the Vibrant capsule as indicated by a satisfaction survey
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.
Measured: end of study (8 weeks after start of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2025
- Study start6 Jan 2026
- Primary completion19 Aug 2026 (estimated)
- Study completion19 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Neurogenic Bowel DysfunctionStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center, HoustonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Mission Connect
- Responsible party
- Principal investigator, Argyrios Stampas, MD, The University of Texas Health Science Center, Houston
- Investigators
- Argyrios Stampas, MD, Principal investigator, The University of Texas Health Science Center, Houston
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07213986
- Sponsor's protocol ID
- HSC-MS-25-0364
- Other IDs
- Project# 0019646
- Status last verified
- Aug 2026
- First submitted
- 6 Oct 2025
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
American College of Gastroenterology Chronic Constipation Task Force. An evidence-based approach to the management of chronic constipation in North America. Am J Gastroenterol. 2005;100 Suppl 1:S1-4. doi: 10.1111/j.1572-0241.2005.50613_1.x. No abstract available.
PubMed 16008640Rao SSC, Lembo A, Chey WD, Friedenberg K, Quigley EMM. Effects of the vibrating capsule on colonic circadian rhythm and bowel symptoms in chronic idiopathic constipation. Neurogastroenterol Motil. 2020 Nov;32(11):e13890. doi: 10.1111/nmo.13890. Epub 2020 May 25.
PubMed 32449277Ron Y, Halpern Z, Safadi R, Dickman R, Dekel R, Sperber AD. Safety and efficacy of the vibrating capsule, an innovative non-pharmacological treatment modality for chronic constipation. Neurogastroenterol Motil. 2015 Jan;27(1):99-104. doi: 10.1111/nmo.12485. Epub 2014 Dec 6.
PubMed 25484196Qi Z, Middleton JW, Malcolm A. Bowel Dysfunction in Spinal Cord Injury. Curr Gastroenterol Rep. 2018 Aug 29;20(10):47. doi: 10.1007/s11894-018-0655-4.
PubMed 30159690
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of the Vibrant Capsule for Spinal Cord Injury Neurogenic Bowel Dysfunction
- ClinicalTrials.gov ID
- NCT07213986
- Acronym / sponsor ID
- HSC-MS-25-0364
- Conditions
- Neurogenic Bowel Dysfunction, Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- The University of Texas Health Science Center, HoustonUniversity, hospital or other
- Collaborators
- Mission Connect
- Study start
- 6 Jan 2026 (actual)
- Primary completion
- 19 Aug 2026 (estimated)
- Study completion
- 19 Aug 2026 (estimated)
- First posted
- 9 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to test the safety and effectiveness of Vibrant capsules in spinal cord injury patients with neurogenic bowel.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Vibrant Capsule | Experimental | Device: Vibrant Capsule |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibrant CapsuleThe 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. | Device | Vibrant Capsule |
Primary outcome
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.
2 secondary outcomes
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 8 with treatment
Feasibility of using the Vibrant capsule as indicated by a satisfaction survey
Time frame: end of study (8 weeks after start of treatment)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
- Background: PubMed 16008640American College of Gastroenterology Chronic Constipation Task Force. An evidence-based approach to the management of chronic constipation in North America. Am J Gastroenterol. 2005;100 Suppl 1:S1-4. doi: 10.1111/j.1572-0241.2005.50613_1.x. No abstract available.
- Background: PubMed 32449277Rao SSC, Lembo A, Chey WD, Friedenberg K, Quigley EMM. Effects of the vibrating capsule on colonic circadian rhythm and bowel symptoms in chronic idiopathic constipation. Neurogastroenterol Motil. 2020 Nov;32(11):e13890. doi: 10.1111/nmo.13890. Epub 2020 May 25.
- Background: PubMed 25484196Ron Y, Halpern Z, Safadi R, Dickman R, Dekel R, Sperber AD. Safety and efficacy of the vibrating capsule, an innovative non-pharmacological treatment modality for chronic constipation. Neurogastroenterol Motil. 2015 Jan;27(1):99-104. doi: 10.1111/nmo.12485. Epub 2014 Dec 6.
- Background: PubMed 30159690Qi Z, Middleton JW, Malcolm A. Bowel Dysfunction in Spinal Cord Injury. Curr Gastroenterol Rep. 2018 Aug 29;20(10):47. doi: 10.1007/s11894-018-0655-4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Danira Garcia Gutierrez, BS contact
Argyrios Stampas, MD principal investigator
The University of Texas Health Science Center, Houston
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibrant Capsule in people with Neurogenic Bowel Dysfunction and Spinal Cord Injury, run by The University of Texas Health Science Center, Houston at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Argyrios Stampas, MD (7127975938, argyrios.stampas@uth.tmc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07213986, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2026.