At-home electrical stimulation for bowel management in spinal cord injury

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study tests the effectiveness of electrical stimulation applied to the skin in the pelvic area to reduce bowel accidents in individuals with spinal cord injuries. Participants will use an FDA-approved TENS device at home for 6-8 hours daily over four weeks, while researchers will compare the effects of active stimulation against a placebo. The study aims to evaluate the feasibility of this approach as an alternative bowel management option, focusing on dosage and adherence. Participants will also maintain a daily diary of their bowel symptoms and stimulation usage.

Why it matters

Who can join: the full rules

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.

Where it's running

• MetroHealth Center for Rehabilitation Research
  Cleveland, Ohio, United States Recruiting

Study contacts

• Principal investigator: Kim Anderson, PhD — MetroHealth System, Ohio
• Study coordinator: Mayson Moore
• Email: mmoore12@metrohealth.org
• Phone: 216-957-3518

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.