Targeting Improvements in Bowel Function and Quality of Life Using Epidural Stimulation and Training After Severe Spinal Cord Injury
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- University of Louisville
- Enrollment
- 36
- Locations
- 4
- Primary Endpoint
- Bowel Diary
Study Overview
Brief Summary
Bowel dysfunction is consistently rated as one of the most common complications affecting daily life for individuals with spinal cord injury. The overall objective of this study is to investigate whether the use of specific spinal cord epidural stimulation will affect bowel function. This study will also examine how alterations in bowel function influence quality of life outcomes. The results of this study may aid in the development of treatments to help individuals with spinal cord injuries that have impaired bowel function.
Detailed Description
Participants in this study must be enrolled in the TS - EPI study (IRB# 16.0179) which provides the spinal cord epidural implant and training interventions. You will receive two sets of interventions, each one lasting 80 sessions for a total of 160 sessions. Assessments for bowel function and quality of life will be performed as part of this study and are conducted at baseline/pre-training, post-Intervention 1, post-Intervention 2, and at the 6-month and 12-month follow-ups. Your participation in this study will last up to 24 months.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Bowel Diary
Time Frame: Change from Baseline after 4 months, 8 months, 14 months, 20 months.
Keep a log of various aspects of your bowel program, including how often and how long it takes you to complete your program.
Ambulatory blood pressure and heart rate monitoring
Time Frame: Change from Baseline after 4 months, 8 months, 14 months, 20 months.
Blood pressure will be recorded over a 24-hour period of time outside the lab using a flexible finger cuff on your non-dominant hand.
Wireless Motility Capsule
Time Frame: Change from Baseline after 4 months, 8 months, 14 months, 20 months.
Use of the FDA approved SmartPill and device to record information about motility.
Anorectal Manometry (ARM)
Time Frame: Change from Baseline after 4 months, 8 months, 14 months, 20 months.
While lying on your side, while a small, flexible tube, about the size of a thermometer, with a balloon at the end will be inserted into the rectum. The catheter is connected to equipment that measures pressure. A small balloon attached to the catheter may be inflated in the rectum to assess muscle responses. You will be asked to relax, squeeze, and push at various times. The anal sphincter muscle pressures are measured during each of these muscle contraction/relaxation actions. Surface patch EMG electrodes will be placed near the buttocks to evaluate muscle activity of the anal sphincter.
International spinal cord injury bowel function basic data set (Version 2.0)
Time Frame: Change from Baseline after 4 months, 8 months, 14 months, 20 months.
Complete a short questionnaire about your bowel management. 16 items: date of data collection, gastrointestinal and anal sphincter dysfunction unrelated to SCI, surgical procedures on the gastrointestinal tract, defecation method and bowel-care procedures, average time required for defecation, frequency of defecation, uneasiness, headache or perspiration during defecation, digital stimulation or evacuation of the anorectum, frequency of fecal incontinence, flatus incontinence, need to wear pad or plug, oral laxatives and prokinetics, anti-diarrheal agents, perianal problems, abdominal pain and discomfort and the neurogenic bowel dysfunction score are computed by adding the points given in parenthesis after each relevant variable in the data-set. Total score range is from (0-45). Total neurogenic bowel score (optional): 0-6 Very minor, 7-9 Minor, 10-13 Moderate, 14 or more, Severe neurogenic bowel dysfunction.
Interviews
Time Frame: Change from Baseline after 4 months, 8 months, 14 months, 20 months.
Interviews about your perspective on changes in bowel management and recovery throughout the study, conducted by a qualitative researcher.
Quality of Life Questionnaire measured with the Spinal Cord Injury - Quality of Life (SCI-QOL) items relevant to bowel management.
Time Frame: Change from Baseline after 4 months, 8 months, 14 months, 20 months.
Complete a series of short questionnaires about your quality of life. SCI-QOL measurements scores range from (0-100). It includes 19 calibrated items banks and 3 fixed length scales spanning the broad domains of physical-medical health, emotional health, social participation and physical functioning.
Secondary Outcomes
No secondary outcomes reported
Investigators
Charles Hubscher
Assistant Professor
University of Louisville