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At-Home Genital Nerve Stimulation for SCI Bowel

RecruitingNAAges 18 Years - anyAllMetroHealth Medical Center
NCT06836739 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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.
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What it tests

  • Genital nerve stimulation
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Where

1 site
MetroHealth Center for Rehabilitation Research
Cleveland, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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