At-Home Feasibility Trial of Genital Nerve Stimulation to Modulate Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Ohio
MetroHealth Center for Rehabilitation Research
RECRUITING
Cleveland
Contact Information
Primary
Mayson Moore
mmoore12@metrohealth.org
216-957-3518
Backup
Megan Hammond Nechols
mhammond1@metrohealth.org
216-957-3562
Time Frame
Start Date: 2025-03-01
Estimated Completion Date: 2026-09-30
Participants
Target number of participants: 12
Treatments
Experimental: Target genital nerve stimulation
Stimulation waveforms consist of biphasic, charge-balanced square pulses with a pulse width of 0.2 ms and delivered at 20 Hz. Stimuli will be applied over a range of amplitudes to determine the threshold of stimulation for producing reflex contraction of the anal sphincter (the pudendo-anal reflex). Subsequent stimulation will be applied at threshold for the first week, at 1.5 threshold for the second week, and at twice threshold (or max tolerance) for the third and fourth weeks. The typical stimulation range is 20-40 milliamps (mA) and has been shown to be well tolerated by individuals with sensation. Stimulation will be applied continuously for 6-8 hours daily for four weeks.
Sham_comparator: Sham genital nerve stimulation
Sham stimulation will be applied in the same manner as target stimulation, except that the stimulation frequency will be 1 Hz and the stimulation amplitude will be set to a limit that is at the threshold of perception if individuals have sensation, or 10 mA if they do not have sensation. Stimulation will be applied continuously for 6-8 hours daily for four weeks.
Related Therapeutic Areas
Sponsors
Leads: MetroHealth Medical Center

This content was sourced from clinicaltrials.gov