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

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.

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.

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