RECRUITING

At-Home Genital Nerve Stimulation for SCI Bowel

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2025-03-01
Study Completion:2026-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06836739

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Traumatic SCI.
  2. 2. Minimum of 6 months' post-injury.
  3. 3. Aged 18 years and older.
  4. 4. Neurological level of injury T12 or higher and AIS grade A-D, as defined by the ISNCSCI.
  5. 5. Score of 14 or higher on the ISCI BF BDS v2.1.
  6. 6. Response to genital nerve stimulation able to be elicited upon screening.
  7. 7. Able to understand and provide informed consent.
  1. 1. Currently enrolled in another functional electrical stimulation (FES) research trial.
  2. 2. Females who are pregnant or planning to become pregnant in the duration of the trial (identified by self-report).
  3. 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. 4. In the judgment of the PI and Co-Investigators, presence of medical complications that may interfere with the execution of the study.

Contacts and Locations

Study Contact

Anvi Kshirsagar
CONTACT
216-957-3558
akshirsagar@metrohealth.org
Megan Hammond Nechols
CONTACT
216-957-3562
mhammond1@metrohealth.org

Principal Investigator

Kim Anderson, PhD
PRINCIPAL_INVESTIGATOR
MetroHealth System, Ohio

Study Locations (Sites)

MetroHealth Center for Rehabilitation Research
Cleveland, Ohio, 44109
United States

Collaborators and Investigators

Sponsor: MetroHealth Medical Center

  • Kim Anderson, PhD, PRINCIPAL_INVESTIGATOR, MetroHealth System, Ohio

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-01
Study Completion Date2026-09-30

Study Record Updates

Study Start Date2025-03-01
Study Completion Date2026-09-30

Terms related to this study

Keywords Provided by Researchers

  • fecal incontinence
  • neurogenic bowel
  • tetraplegia
  • paraplegia
  • paralysis
  • electrical stimulation
  • neuromodulation
  • bowel
  • feasibility
  • anorectal manometry

Additional Relevant MeSH Terms

  • Spinal Cord Injury