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| ID | Type | Description | Link |
|---|---|---|---|
| Project# 0019646 | Other Grant/Funding Number | Misssion Connect |
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| Name | Class |
|---|---|
| Mission Connect | UNKNOWN |
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The goal of this study is to test the safety and effectiveness of Vibrant capsules in spinal cord injury patients with 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) 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vibrant Capsule | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of Vibrant capsule as indicated by number of participants who had an adverse event | 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 | week 1 with treatment, week 2 with treatment, week 3 with treatment, week 4 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. | 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. | week 1 with treatment, week 2 with treatment, week 3 with treatment, week 4 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. | 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. | week 1 with treatment, week 2 with treatment, week 3 with treatment, week 4 with treatment |
| Safety as assessed by the Neurogenic Bladder Symptom Score (NBSS) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | from week 1 with treatment to week 4 with treatment |
| Feasibility of using the Vibrant capsule as indicated by a satisfaction survey |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Argyrios Stampas, MD | Contact | 7127975938 | argyrios.stampas@uth.tmc.edu | |
| Danira Garcia Gutierrez, BS | Contact | 7137977133 |
| Name | Affiliation | Role |
|---|---|---|
| Argyrios Stampas, MD | The University of Texas Health Science Center, Houston | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| TIRR Memorial Hermann | Recruiting | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16008640 | Background | 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. | |
| 32449277 | Background | Rao 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. |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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The Neurogenic Bladder Symptom Score (NBSS) ranges from 0 to 96, with a higher score indicating greater Neurogenic Bladder Symptoms. |
| 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. | week 1 with treatment, week 4 with 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. |
| end of study (4 weeks after start of treatment) |
| 25484196 | Background | Ron 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. |
| 30159690 | Background | Qi 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. |
| D014947 | Wounds and Injuries |