At-Home Genital Nerve Stimulation for SCI Bowel
A legfontosabb adatok
- Hol
- Cleveland (Egyesült Államok)A helyszín megnézése
Helyszínek itt: Egyesült Államok
- MetroHealth Center for Rehabilitation ResearchCleveland, Egyesült ÁllamokContact: Mayson MooreRésztvevőt keres
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- MetroHealth Medical Center
- Azonosító
- NCT06836739
- A regiszteradat frissítve
- 2026. november 3.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
At-Home Feasibility Trial of Genital Nerve Stimulation to Modulate Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury
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
Bevonási feltételek: Traumatic SCI; Minimum of 6 months' post-injury; Aged 18 years and older; Neurological level of injury T12 or higher and AIS grade A-D, as defined by the ISNCSCI; Score of 14 or higher on the ISCI BF BDS v2.1; Response to genital nerve stimulation able to be elicited upon screening; Able to understand and provide informed consent.
Kizáró feltételek: 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; Currently enrolled in another functional electrical stimulation (FES) research trial; Females who are pregnant or planning to become pregnant in the duration of the trial (identified by self-report); In the judgment of the PI and Co-Investigators, presence of medical complications that may interfere with the execution of the study.