Improving Bowel Function and Quality of Life After Spinal Cord Injury

NCT03949660 | Unknown DMC FDA Device

• 1 other identifier: 19.0435
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 2

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.

Conditions

Neurogenic Bowel

Keywords

bowel; spinal cord injury; epidural stimulation

Outcome Measures

Primary Outcomes (7)

• Wireless Motility Capsule

  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

  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)

  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

  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)

  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.

  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

  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.

Study Arms (4)

Epidural stimulation for blood pressure without stand

EXPERIMENTAL

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

Device: Stimulation for blood pressure without stand

Epidural stimulation for blood pressure with stand

EXPERIMENTAL

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

Device: Stimulation for blood pressure with stand

Epidural stimulation for trunk and core without stand

EXPERIMENTAL

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

Device: Stimulation for trunk and core without stand

Epidural stimulation for trunk and core with stand

EXPERIMENTAL

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

Device: Stimulation for trunk or core with stand

Interventions

Stimulation for blood pressure without stand DEVICE

Consists of 80 daily training sessions using epidural stimulation optimized for blood pressure for up to 6 hours of stimulation a day.

Epidural stimulation for blood pressure without stand

Stimulation for blood pressure with stand DEVICE

Consists of 80 daily sessions similar to the 1st intervention (without stand) plus 2 hours of epidural stimulation optimized for stand training.

Epidural stimulation for blood pressure with stand

Stimulation for trunk and core without stand DEVICE

Consists of 80 daily training sessions using epidural stimulation optimized for trunk/core/voluntary function for up to 6 hours of stimulation a day.

Epidural stimulation for trunk and core without stand

Stimulation for trunk or core with stand DEVICE

Consists of 80 daily sessions similar to the 1st intervention (without stand) plus 2 hours of epidural stimulation optimized for stand training.

Epidural stimulation for trunk and core with stand

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Louisville: lead

Study Sites (2)

Frazier Rehab Institute

Louisville, Kentucky, 40202, United States

RECRUITING

University of Louisville

Louisville, Kentucky, 40202, United States

RECRUITING

MeSH Terms

Conditions

Neurogenic Bowel; Spinal Cord Injuries

Interventions

Blood Pressure

Condition Hierarchy (Ancestors)

Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Central Study Contacts

Susan Harkema, PhD

CONTACT

502-581-8747; susan.harkema@louisville.edu

Lee Ann Zeller-Noe

CONTACT

502-581-8747; lee.zellernoe@louisville.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 7, 2019
• First Posted: May 14, 2019
• Study Start: September 15, 2018
• Primary Completion: September 15, 2024
• Study Completion: December 15, 2024
• Last Updated: October 27, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)