- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03949660
Improving Bowel Function and Quality of Life After Spinal Cord Injury
Targeting Improvements in Bowel Function and Quality of Life Using Epidural Stimulation and Training After Severe Spinal Cord Injury
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Susan Harkema, PhD
- Phone Number: 502-581-8747
- Email: susan.harkema@louisville.edu
Study Contact Backup
- Name: Lee Ann Zeller-Noe
- Phone Number: 502-581-8747
- Email: lee.zellernoe@louisville.edu
Study Locations
-
-
Kentucky
-
Louisville, Kentucky, United States, 40202
- Recruiting
- University of Louisville
-
Contact:
- Susan Harkema, PhD
-
Louisville, Kentucky, United States, 40202
- Recruiting
- Frazier Rehab Institute
-
Contact:
- Susan Harkema, PhD
- Phone Number: 502-581-8747
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Epidural stimulation for blood pressure without stand
To assess whether epidural stimulation, used for regulating blood pressure without standing, is neuromodulatory for bowel motility after motor complete SCI
|
Consists of 80 daily training sessions using epidural stimulation optimized for blood pressure for up to 6 hours of stimulation a day.
|
Experimental: Epidural stimulation for blood pressure with stand
To assess whether epidural stimulation, used for regulating blood pressure with standing, is neuromodulatory for bowel motility after motor complete SCI
|
Consists of 80 daily sessions similar to the 1st intervention (without stand) plus 2 hours of epidural stimulation optimized for stand training.
|
Experimental: Epidural stimulation for trunk and core without stand
To assess whether epidural stimulation, used for activating the trunk and core musculature without standing, is neuromodulatory for bowel evacuation after motor complete SCI
|
Consists of 80 daily training sessions using epidural stimulation optimized for trunk/core/voluntary function for up to 6 hours of stimulation a day.
|
Experimental: Epidural stimulation for trunk and core with stand
To assess whether epidural stimulation, used for activating the trunk and core musculature with standing, is neuromodulatory for bowel evacuation after motor complete SCI
|
Consists of 80 daily sessions similar to the 1st intervention (without stand) plus 2 hours of epidural stimulation optimized for stand training.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Change from Baseline after 4 months, 8 months, 14 months, 20 months.
|
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.
|
Change from Baseline after 4 months, 8 months, 14 months, 20 months.
|
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. |
Change from Baseline after 4 months, 8 months, 14 months, 20 months.
|
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.
|
Change from Baseline after 4 months, 8 months, 14 months, 20 months.
|
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.
|
Change from Baseline after 4 months, 8 months, 14 months, 20 months.
|
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.
|
Change from Baseline after 4 months, 8 months, 14 months, 20 months.
|
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.
|
Change from Baseline after 4 months, 8 months, 14 months, 20 months.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19.0435
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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