Short-term Genital Nerve Stimulation to Modulate Anorectal Reflex Activity in Neurogenic Bowel Dysfunction in Individuals Living With Spinal Cord Injury

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

Bowel issues occur in nearly all people after spinal cord injury (SCI) and one major complication is fecal incontinence (accidents). This complication has been repeatedly highlighted by people living with SCI as particularly life-limiting and in need of more options for interventions. This study will test the effect of genital nerve stimulation (GNS), with non-invasive electrodes, on the activity of the anus and rectum of persons after SCI. Recording anorectal manometry (ARM) endpoints tells us the function of those tissues and our study design (ARM without stim, ARM with stim, ARM without stim) will allow us to conclude the GNS effect and whether it is likely to reduce fecal incontinence. The study will also collect medical, demographic, and bowel related functional information. The combination of all of these data should help predict who will respond to stimulation, what will happen when stimulation is applied, and if that stimulation is likely to provide an improvement in fecal continence for people living with SCI.

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

• Traumatic SCI

• Minimum 6 months post-injury

• Aged 18 years or older

• Neurological level of injury T12 or higher AIS grade A-D defined by ISNCSCI

• Response to genital nerve stimulation upon screening

• Able to understand and provide informed consent

Locations
United States
Ohio
MetroHealth Medical System Old Brooklyn Campus
RECRUITING
Cleveland
Contact Information
Primary
Mayson Moore
MMoore12@metrohealth.org
2169573558
Backup
Rob Hoey, PhD
rhoey@metrohealth.org
2169573665
Time Frame
Start Date: 2023-03-21
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 52
Treatments
Experimental: All interventions, Sham applied first
These participants will have all interventions applied, but will be randomly designated to have sham stimulation applied before effective stimulation. This will balance any issue with order of presentation of multiple stimulation sessions.
Experimental: All interventions, effective stim applied first
These participants will have all interventions applied, but will be randomly designated to have effective stimulation applied before sham stimulation. This will balance any issue with order of presentation of multiple stimulation sessions.
Related Therapeutic Areas
Sponsors
Leads: MetroHealth Medical Center
Collaborators: VA of Northeast Ohio Health System

This content was sourced from clinicaltrials.gov