Neurogenic Bowel Dysfunction, Spinal Cord Injury
Conditions
Brief summary
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.
Interventions
DEVICEVibrant 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.
Sponsors
The University of Texas Health Science Center, Houston
Mission Connect
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 assessed by the Penn Spasm Frequency Scale (PSFS) | 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 as assessed by average weekly Numerical Pain Score | 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 the Neurogenic Bladder Symptom Score (NBSS) | baseline, week 3 | The Neurogenic Bladder Symptom Score (NBSS) ranges from 0 to 96, with a higher score indicating greater Neurogenic Bladder Symptoms. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility as indicated by the number of participants that adhere to the prescribed use of Vibrant | from week 1 with treatment to week 8 with treatment | Feasibility of the Vibrant capsule will be recorded in this patient population by adherence to the protocol. |
| Feasibility of using the Vibrant capsule as indicated by a satisfaction survey | end of study (8 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. |
Countries
United States
Contacts
CONTACTArgyrios Stampas, MD
CONTACTDanira Garcia Gutierrez, BS
PRINCIPAL_INVESTIGATORArgyrios Stampas, MD
The University of Texas Health Science Center, Houston
Outcome results
None listed