At-Home Genital Nerve Stimulation for SCI Bowel
ConditionSpinal Cord Injury
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMetroHealth Medical Center
About this trial
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
Eligibility criteria
Qualifiers
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.
Disqualifiers
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).
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.
In the judgment of the PI and Co-Investigators, presence of medical complications that may interfere with the execution of the study.
Trial design
Treatments tested in this trial
- Genital nerve stimulation
Treatment groups
12 Participants
are divided into 2 treatment groupsSponsors and collaborators
MetroHealth Medical Center
Lead sponsor
Congressionally Directed Medical Research Programs
Collaborator
Source ClinicalTrials.gov