NCT03949660

Improving Bowel Function and Quality of Life After Spinal Cord Injury

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: University of Louisville · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neurogenic Bowel

Interventions

Type	Name	Description
DEVICE	Stimulation for blood pressure without stand	Consists of 80 daily training sessions using epidural stimulation optimized for blood pressure for up to 6 hours of stimulation a day.
DEVICE	Stimulation for blood pressure with stand	Consists of 80 daily sessions similar to the 1st intervention (without stand) plus 2 hours of epidural stimulation optimized for stand training.
DEVICE	Stimulation for trunk and core without stand	Consists of 80 daily training sessions using epidural stimulation optimized for trunk/core/voluntary function for up to 6 hours of stimulation a day.
DEVICE	Stimulation for trunk or core with stand	Consists of 80 daily sessions similar to the 1st intervention (without stand) plus 2 hours of epidural stimulation optimized for stand training.

Timeline

• Start date: 2018-09-15
• Primary completion: 2024-09-15
• Completion: 2024-12-15
• First posted: 2019-05-14
• Last updated: 2023-10-27

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study