Improving bowel function and quality of life for spinal cord injury patients
Targeting Improvements in Bowel Function and Quality of Life Using Epidural Stimulation and Training After Severe Spinal Cord Injury
This study is testing if spinal cord epidural stimulation can improve bowel function and quality of life for people with spinal cord injuries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 36 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Louisville Academic / other |
| Locations | 2 sites (Louisville, Kentucky and 1 other locations) |
| Trial ID | NCT03949660 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of spinal cord epidural stimulation on bowel function in individuals with spinal cord injuries. Participants will undergo two sets of interventions, each consisting of 80 sessions, while their bowel function and quality of life will be assessed at various points throughout the study. The goal is to determine if these interventions can improve bowel function and, consequently, enhance the quality of life for those affected. The study will last up to 24 months and requires participants to be enrolled in a related study providing the spinal cord epidural implant.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with non-progressive spinal cord injuries who experience bowel dysfunction.
Not a fit: Patients who are ventilator dependent, have untreated psychiatric disorders, or have bowel dysfunction unrelated to spinal cord injury may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved bowel function and quality of life for individuals with spinal cord injuries.
How similar studies have performed: Other studies have shown promise in using spinal cord stimulation for various functions, but this specific approach to bowel function is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * At least 18 years of age at the time of enrollment * At least 2 years post injury * Non-progressive spinal cord injury * Stable medical condition * Unable to voluntarily move all joints of the legs * Unable to stand independently * Cardiovascular dysfunction including presence of persistent resting low blood pressures and/or symptoms of autonomic dysreflexia and/or orthostatic hypotension and/or dysregulation in response to postural changes and/or highly variable blood pressures in 24 hour period * Bowel dysfunction as a result of spinal cord injury Exclusion Criteria: * Ventilator dependent * Untreated painful musculoskeletal dysfunction, unhealed fracture or pressure sore * Untreated psychiatric disorder or ongoing drug abuse * Colostomy bag * Any implanted pump (i.e., baclofen pump, pain pump, etc) * Cardiovascular or bowel dysfunction unrelated to SCI * Ongoing nicotine use * Pregnant at the time of enrollment or planning to become pregnant during the time course of the study
Where this trial is running
Louisville, Kentucky and 1 other locations
- Frazier Rehab Institute — Louisville, Kentucky, United States (Recruiting)
- University of Louisville — Louisville, Kentucky, United States (Recruiting)
Study contacts
- Study coordinator: Susan Harkema, PhD
- Email: susan.harkema@louisville.edu
- Phone: 502-581-8747
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.