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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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

Locations
United States
Kentucky
Frazier Rehab Institute
RECRUITING
Louisville
University of Louisville
RECRUITING
Louisville
Contact Information
Primary
Susan Harkema, PhD
susan.harkema@louisville.edu
502-581-8747
Backup
Lee Ann Zeller-Noe
lee.zellernoe@louisville.edu
502-581-8747
Time Frame
Start Date: 2018-09-15
Estimated Completion Date: 2024-12-15
Participants
Target number of participants: 36
Treatments
Experimental: Epidural stimulation for blood pressure without stand
To assess whether epidural stimulation, used for regulating blood pressure without standing, is neuromodulatory for bowel motility after motor complete SCI
Experimental: Epidural stimulation for blood pressure with stand
To assess whether epidural stimulation, used for regulating blood pressure with standing, is neuromodulatory for bowel motility after motor complete SCI
Experimental: Epidural stimulation for trunk and core without stand
To assess whether epidural stimulation, used for activating the trunk and core musculature without standing, is neuromodulatory for bowel evacuation after motor complete SCI
Experimental: Epidural stimulation for trunk and core with stand
To assess whether epidural stimulation, used for activating the trunk and core musculature with standing, is neuromodulatory for bowel evacuation after motor complete SCI
Related Therapeutic Areas
Sponsors
Leads: University of Louisville

This content was sourced from clinicaltrials.gov