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Improving Bowel Function and Quality of Life After Spinal Cord Injury

Primary Purpose

Neurogenic Bowel

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Stimulation for blood pressure without stand
Stimulation for blood pressure with stand
Stimulation for trunk and core without stand
Stimulation for trunk or core with stand
Sponsored by
University of Louisville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neurogenic Bowel focused on measuring bowel, spinal cord injury, epidural stimulation

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Frazier Rehab InstituteRecruiting
  • University of LouisvilleRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Epidural stimulation for blood pressure without stand

Epidural stimulation for blood pressure with stand

Epidural stimulation for trunk and core without stand

Epidural stimulation for trunk and core with stand

Arm Description

To assess whether epidural stimulation, used for regulating blood pressure without standing, is neuromodulatory for bowel motility after motor complete SCI

To assess whether epidural stimulation, used for regulating blood pressure with standing, is neuromodulatory for bowel motility after motor complete SCI

To assess whether epidural stimulation, used for activating the trunk and core musculature without standing, is neuromodulatory for bowel evacuation after motor complete SCI

To assess whether epidural stimulation, used for activating the trunk and core musculature with standing, is neuromodulatory for bowel evacuation after motor complete SCI

Outcomes

Primary Outcome Measures

Wireless Motility Capsule
Use of the FDA approved SmartPill and device to record information about motility.
Ambulatory blood pressure and heart rate monitoring
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)
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
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)
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.
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
Interviews about your perspective on changes in bowel management and recovery throughout the study, conducted by a qualitative researcher.

Secondary Outcome Measures

Full Information

First Posted
May 7, 2019
Last Updated
February 10, 2023
Sponsor
University of Louisville
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1. Study Identification

Unique Protocol Identification Number
NCT03949660
Brief Title
Improving Bowel Function and Quality of Life After Spinal Cord Injury
Official Title
Targeting Improvements in Bowel Function and Quality of Life Using Epidural Stimulation and Training After Severe Spinal Cord Injury
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 15, 2018 (Actual)
Primary Completion Date
September 15, 2023 (Anticipated)
Study Completion Date
December 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neurogenic Bowel
Keywords
bowel, spinal cord injury, epidural stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Epidural stimulation for blood pressure without stand
Arm Type
Experimental
Arm Description
To assess whether epidural stimulation, used for regulating blood pressure without standing, is neuromodulatory for bowel motility after motor complete SCI
Arm Title
Epidural stimulation for blood pressure with stand
Arm Type
Experimental
Arm Description
To assess whether epidural stimulation, used for regulating blood pressure with standing, is neuromodulatory for bowel motility after motor complete SCI
Arm Title
Epidural stimulation for trunk and core without stand
Arm Type
Experimental
Arm Description
To assess whether epidural stimulation, used for activating the trunk and core musculature without standing, is neuromodulatory for bowel evacuation after motor complete SCI
Arm Title
Epidural stimulation for trunk and core with stand
Arm Type
Experimental
Arm Description
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 Type
Device
Intervention Name(s)
Stimulation for blood pressure without stand
Intervention Description
Consists of 80 daily training sessions using epidural stimulation optimized for blood pressure for up to 6 hours of stimulation a day.
Intervention Type
Device
Intervention Name(s)
Stimulation for blood pressure with stand
Intervention Description
Consists of 80 daily sessions similar to the 1st intervention (without stand) plus 2 hours of epidural stimulation optimized for stand training.
Intervention Type
Device
Intervention Name(s)
Stimulation for trunk and core without stand
Intervention Description
Consists of 80 daily training sessions using epidural stimulation optimized for trunk/core/voluntary function for up to 6 hours of stimulation a day.
Intervention Type
Device
Intervention Name(s)
Stimulation for trunk or core with stand
Intervention Description
Consists of 80 daily sessions similar to the 1st intervention (without stand) plus 2 hours of epidural stimulation optimized for stand training.
Primary Outcome Measure Information:
Title
Wireless Motility Capsule
Description
Use of the FDA approved SmartPill and device to record information about motility.
Time Frame
Change from Baseline after 4 months, 8 months, 14 months, 20 months.
Title
Ambulatory blood pressure and heart rate monitoring
Description
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.
Time Frame
Change from Baseline after 4 months, 8 months, 14 months, 20 months.
Title
Anorectal Manometry (ARM)
Description
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.
Time Frame
Change from Baseline after 4 months, 8 months, 14 months, 20 months.
Title
Bowel Diary
Description
Keep a log of various aspects of your bowel program, including how often and how long it takes you to complete your program.
Time Frame
Change from Baseline after 4 months, 8 months, 14 months, 20 months.
Title
International spinal cord injury bowel function basic data set (Version 2.0)
Description
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.
Time Frame
Change from Baseline after 4 months, 8 months, 14 months, 20 months.
Title
Quality of Life Questionnaire measured with the Spinal Cord Injury - Quality of Life (SCI-QOL) items relevant to bowel management.
Description
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.
Time Frame
Change from Baseline after 4 months, 8 months, 14 months, 20 months.
Title
Interviews
Description
Interviews about your perspective on changes in bowel management and recovery throughout the study, conducted by a qualitative researcher.
Time Frame
Change from Baseline after 4 months, 8 months, 14 months, 20 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Susan Harkema, PhD
Phone
502-581-8747
Email
susan.harkema@louisville.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Lee Ann Zeller-Noe
Phone
502-581-8747
Email
lee.zellernoe@louisville.edu
Facility Information:
Facility Name
Frazier Rehab Institute
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Harkema, PhD
Phone
502-581-8747
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Harkema, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Improving Bowel Function and Quality of Life After Spinal Cord Injury

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