Don't get left behind! The modernized ClinicalTrials.gov is coming. Check it out now.
Say goodbye to ClinicalTrials.gov!
The new site is coming soon - go to the modernized ClinicalTrials.gov
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Improving Bowel Function and Quality of Life After Spinal Cord Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03949660
Recruitment Status : Recruiting
First Posted : May 14, 2019
Last Update Posted : February 14, 2023
Sponsor:
Information provided by (Responsible Party):
Charles Hubscher, University of Louisville

Tracking Information
First Submitted Date  ICMJE May 7, 2019
First Posted Date  ICMJE May 14, 2019
Last Update Posted Date February 14, 2023
Actual Study Start Date  ICMJE September 15, 2018
Estimated Primary Completion Date September 15, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 10, 2019)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Improving Bowel Function and Quality of Life After Spinal Cord Injury
Official Title  ICMJE Targeting Improvements in Bowel Function and Quality of Life Using Epidural Stimulation and Training After Severe Spinal Cord Injury
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Neurogenic Bowel
Intervention  ICMJE
  • Device: Stimulation for blood pressure without stand
    Consists of 80 daily training sessions using epidural stimulation optimized for blood pressure for up to 6 hours of stimulation a day.
  • Device: Stimulation for blood pressure with stand
    Consists of 80 daily sessions similar to the 1st intervention (without stand) plus 2 hours of epidural stimulation optimized for stand training.
  • Device: Stimulation for trunk and core without stand
    Consists of 80 daily training sessions using epidural stimulation optimized for trunk/core/voluntary function for up to 6 hours of stimulation a day.
  • Device: Stimulation for trunk or core with stand
    Consists of 80 daily sessions similar to the 1st intervention (without stand) plus 2 hours of epidural stimulation optimized for stand training.
Study Arms  ICMJE
  • 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
    Intervention: Device: Stimulation for blood pressure without stand
  • 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
    Intervention: Device: Stimulation for blood pressure with stand
  • 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
    Intervention: Device: Stimulation for trunk and core without stand
  • 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
    Intervention: Device: Stimulation for trunk or core with stand
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 10, 2019)		 36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 15, 2023
Estimated Primary Completion Date September 15, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Susan Harkema, PhD 502-581-8747 susan.harkema@louisville.edu
Contact: Lee Ann Zeller-Noe 502-581-8747 lee.zellernoe@louisville.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03949660
Other Study ID Numbers  ICMJE 19.0435
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Charles Hubscher, University of Louisville
Original Responsible Party April Herrity, University of Louisville, Assistant Professor
Current Study Sponsor  ICMJE University of Louisville
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Louisville
Verification Date February 2023

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP