Improving Bowel Function and Quality of Life After Spinal Cord Injury
NCT ID: NCT03949660
Last Updated: 2023-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
36 participants
INTERVENTIONAL
2018-09-15
2024-12-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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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
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.
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
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.
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
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.
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
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.
Interventions
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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.
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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University of Louisville
OTHER
Responsible Party
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Charles Hubscher
Assistant Professor
Locations
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Frazier Rehab Institute
Louisville, Kentucky, United States
University of Louisville
Louisville, Kentucky, United States
Countries
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Central Contacts
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Facility Contacts
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Susan Harkema, PhD
Role: primary
Susan Harkema, PhD
Role: primary
Other Identifiers
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19.0435
Identifier Type: -
Identifier Source: org_study_id
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