Actively Recruiting
At-Home Genital Nerve Stimulation for SCI Bowel
Led by MetroHealth Medical Center · Updated on 2025-12-02
12
Participants Needed
1
Research Sites
82 weeks
Total Duration
On this page
Sponsors
M
MetroHealth Medical Center
Lead Sponsor
C
Congressionally Directed Medical Research Programs
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to test whether electrical stimulation of the skin in the pelvic area (near the genitals) can reduce the reflexes that cause bowel accidents in people with spinal cord injuries. Current bowel treatments either involve diet and medications or surgery. This study will evaluate whether electrical stimulation can be an alternate option for bowel management. Researchers will: * Use an FDA approved Transcutaneous Electrical Nerve Stimulation (TENS) device off-label * Compare a target stimulation level to a placebo stimulation level Participants will: * Use electrical stimulation on the skin in the pelvic area for 6-8 hours each day for 4 weeks at home * Visit the research center 3 times to participate in exams and answer questions * Keep a daily diary of their bowel symptoms and stimulation times
CONDITIONS
Official Title
At-Home Genital Nerve Stimulation for SCI Bowel
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Traumatic spinal cord injury
- At least 6 months since injury
- Aged 18 years or older
- Neurological injury level at T12 or above with AIS grade A-D
- Score of 14 or higher on the ISCI BF BDS v2.1
- Able to have a genital nerve stimulation response at screening
- Able to understand and give informed consent
You will not qualify if you...
- Currently enrolled in another functional electrical stimulation research trial
- Pregnant women or planning pregnancy during the trial
- Having a cardiac pacemaker, implanted defibrillator, or other implanted electrical stimulation device that may interact with GNS
- Medical complications judged by investigators to interfere with study participation
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
MetroHealth Center for Rehabilitation Research
Cleveland, Ohio, United States, 44109
Actively Recruiting
Research Team
M
Mayson Moore
CONTACT
M
Megan Hammond Nechols
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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