Clinical trial NCT03949660: Improving Bowel Function and Quality of Life After Spinal Cord Injury
Official title: Targeting Improvements in Bowel Function and Quality of Life Using Epidural Stimulation and Training After Severe Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neurogenic Bowel
Keywords: bowel
spinal cord injury
epidural stimulation
Lead sponsor: University of Louisville
Sponsor class: OTHER
First posted: 2019-05-14
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief 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.

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

Primary outcomes:
measure: Wireless Motility Capsule
timeFrame: Change from Baseline after 4 months, 8 months, 14 months, 20 months.
measure: Ambulatory blood pressure and heart rate monitoring
timeFrame: Change from Baseline after 4 months, 8 months, 14 months, 20 months.
measure: Anorectal Manometry (ARM)
timeFrame: Change from Baseline after 4 months, 8 months, 14 months, 20 months.
measure: Bowel Diary
timeFrame: Change from Baseline after 4 months, 8 months, 14 months, 20 months.
measure: International spinal cord injury bowel function basic data set (Version 2.0)
timeFrame: Change from Baseline after 4 months, 8 months, 14 months, 20 months.
measure: Quality of Life Questionnaire measured with the Spinal Cord Injury - Quality of Life (SCI-QOL) items relevant to bowel management.
timeFrame: Change from Baseline after 4 months, 8 months, 14 months, 20 months.
measure: Interviews
timeFrame: Change from Baseline after 4 months, 8 months, 14 months, 20 months.
Secondary outcomes:
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Frazier Rehab Institute
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
Study officials:
References: