Improving Bowel Function and Quality of Life After Spinal Cord Injury

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Primary Purpose

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

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

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

NCT ID

NCT03949660

First Posted

May 7, 2019

Last Updated

February 10, 2023

Sponsor

University of Louisville

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