Improving Bowel Function and Quality of Life After Spinal Cord Injury

University of Louisville (UOFL)

Status: Enrolling

Conditions: Neurogenic Bowel

Treatments: Device: Stimulation for trunk or core with stand; Device: Stimulation for trunk and core without stand; Device: Stimulation for blood pressure with stand; Device: Stimulation for blood pressure without stand

Study type: Interventional

Funder types: Other

Identifiers

NCT03949660

19.0435

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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36 participants in 4 patient groups

Epidural stimulation for blood pressure without stand

Experimental group

Description:

To assess whether epidural stimulation, used for regulating blood pressure without standing, is neuromodulatory for bowel motility after motor complete SCI

Treatment:

Device: Stimulation for blood pressure without stand

Epidural stimulation for blood pressure with stand

Experimental group

Description:

To assess whether epidural stimulation, used for regulating blood pressure with standing, is neuromodulatory for bowel motility after motor complete SCI

Treatment:

Device: Stimulation for blood pressure with stand

Epidural stimulation for trunk and core without stand

Experimental group

Description:

To assess whether epidural stimulation, used for activating the trunk and core musculature without standing, is neuromodulatory for bowel evacuation after motor complete SCI

Treatment:

Device: Stimulation for trunk and core without stand

Epidural stimulation for trunk and core with stand

Experimental group

Description:

To assess whether epidural stimulation, used for activating the trunk and core musculature with standing, is neuromodulatory for bowel evacuation after motor complete SCI

Treatment:

Device: Stimulation for trunk or core with stand