At-home electrical stimulation for bowel management in spinal cord injury
At-Home Feasibility Trial of Genital Nerve Stimulation to Modulate Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
This study is testing if using a special electrical device at home can help people with spinal cord injuries have fewer bowel accidents.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | MetroHealth Medical Center Academic / other |
| Locations | 1 site (Cleveland, Ohio) |
| Trial ID | NCT06836739 on ClinicalTrials.gov |
What this trial studies
This study tests the effectiveness of electrical stimulation applied to the skin in the pelvic area to reduce bowel accidents in individuals with spinal cord injuries. Participants will use an FDA-approved TENS device at home for 6-8 hours daily over four weeks, while researchers will compare the effects of active stimulation against a placebo. The study aims to evaluate the feasibility of this approach as an alternative bowel management option, focusing on dosage and adherence. Participants will also maintain a daily diary of their bowel symptoms and stimulation usage.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with traumatic spinal cord injuries at least six months post-injury and specific neurological injury levels.
Not a fit: Patients currently enrolled in other electrical stimulation trials or those with certain medical devices or complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a non-invasive alternative for managing bowel dysfunction in patients with spinal cord injuries.
How similar studies have performed: While the approach of using electrical stimulation for bowel management is innovative, similar studies have shown promise in related areas, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Traumatic SCI. 2. Minimum of 6 months' post-injury. 3. Aged 18 years and older. 4. Neurological level of injury T12 or higher and AIS grade A-D, as defined by the ISNCSCI. 5. Score of 14 or higher on the ISCI BF BDS v2.1. 6. Response to genital nerve stimulation able to be elicited upon screening. 7. Able to understand and provide informed consent. Exclusion Criteria: 1. Currently enrolled in another functional electrical stimulation (FES) research trial. 2. Females who are pregnant or planning to become pregnant in the duration of the trial (identified by self-report). 3. Presence of a cardiac pacemaker, implanted defibrillator, or other implanted functional electrical stimulation device if, upon clinical evaluation, it may have an interaction with GNS. 4. In the judgment of the PI and Co-Investigators, presence of medical complications that may interfere with the execution of the study.
Where this trial is running
Cleveland, Ohio
- MetroHealth Center for Rehabilitation Research — Cleveland, Ohio, United States (Recruiting)
Study contacts
- Principal investigator: Kim Anderson, PhD — MetroHealth System, Ohio
- Study coordinator: Mayson Moore
- Email: mmoore12@metrohealth.org
- Phone: 216-957-3518
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.