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New treatment option for Spinal Cord Injury
Official title At-Home Genital Nerve Stimulation for SCI Bowel
ClinicalTrials.gov ID: NCT06836739
What this study is testing
- What it's testing
- 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.
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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.
You likely can't join if
- 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...
- In the judgment of the PI and Co-Investigators, presence of medical complications that may interfere with the execution of the study.
See the full eligibility criteria
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Cleveland, Ohio, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Cleveland, Ohio, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.