RECRUITING

Improving Bowel Function and Quality of Life After Spinal Cord Injury

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Targeting Improvements in Bowel Function and Quality of Life Using Epidural Stimulation and Training After Severe Spinal Cord Injury

Quick Facts

Study Start:2018-09-15
Study Completion:2024-12-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT03949660

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * At least 18 years of age at the time of enrollment
  2. * At least 2 years post injury
  3. * Non-progressive spinal cord injury
  4. * Stable medical condition
  5. * Unable to voluntarily move all joints of the legs
  6. * Unable to stand independently
  7. * 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
  8. * Bowel dysfunction as a result of spinal cord injury
  1. * Ventilator dependent
  2. * Untreated painful musculoskeletal dysfunction, unhealed fracture or pressure sore
  3. * Untreated psychiatric disorder or ongoing drug abuse
  4. * Colostomy bag
  5. * Any implanted pump (i.e., baclofen pump, pain pump, etc)
  6. * Cardiovascular or bowel dysfunction unrelated to SCI
  7. * Ongoing nicotine use
  8. * Pregnant at the time of enrollment or planning to become pregnant during the time course of the study

Contacts and Locations

Study Contact

Susan Harkema, PhD
CONTACT
502-581-8747
susan.harkema@louisville.edu
Lee Ann Zeller-Noe
CONTACT
502-581-8747
lee.zellernoe@louisville.edu

Study Locations (Sites)

Frazier Rehab Institute
Louisville, Kentucky, 40202
United States
University of Louisville
Louisville, Kentucky, 40202
United States

Collaborators and Investigators

Sponsor: University of Louisville

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-09-15
Study Completion Date2024-12-15

Study Record Updates

Study Start Date2018-09-15
Study Completion Date2024-12-15

Terms related to this study

Keywords Provided by Researchers

  • bowel
  • spinal cord injury
  • epidural stimulation

Additional Relevant MeSH Terms

  • Neurogenic Bowel