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Search / Trial NCT03949660

Improving Bowel Function and Quality of Life After Spinal Cord Injury

Launched by UNIVERSITY OF LOUISVILLE · May 10, 2019

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Bowel Spinal Cord Injury Epidural Stimulation

ClinConnect Summary

This clinical trial is looking at how a specific treatment called spinal cord epidural stimulation can improve bowel function and overall quality of life for people who have experienced a spinal cord injury. Many individuals with spinal cord injuries struggle with bowel dysfunction, which can significantly impact their daily lives. By studying this treatment, researchers hope to find new ways to help those affected.

To participate in the trial, individuals must be at least 18 years old and have had a spinal cord injury for at least two years. They should also have difficulty moving their legs and standing independently. Participants will not be able to have certain medical conditions, like being on a ventilator or having untreated pain or psychiatric issues. If eligible, participants can expect to be part of a study that aims to improve their bowel function, which could lead to a better quality of life. It's important to note that the trial is currently recruiting participants of all genders within a wide age range.

Gender

ALL

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

About University Of Louisville

The University of Louisville is a distinguished academic institution known for its commitment to advancing medical research and clinical innovation. As a clinical trial sponsor, the university leverages its extensive resources and expertise to conduct pioneering studies that aim to improve patient outcomes and enhance healthcare practices. With a focus on interdisciplinary collaboration and community engagement, the University of Louisville fosters an environment conducive to groundbreaking research across various medical fields, ensuring adherence to the highest ethical standards and regulatory compliance. Through its clinical trials, the university seeks to translate scientific discoveries into tangible benefits for patients and the broader community.

Locations

Louisville, Kentucky, United States

Louisville, Kentucky, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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