Spinal Cord Stimulation for Neurogenic Bowel Due to Spinal Cord Injury

Recruiting in Palo Alto (17 mi)

+1 other location

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: University of Louisville

No Placebo Group

Trial Summary

What is the purpose of this trial?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 Criteria

This trial is for adults over 18 with non-progressive spinal cord injury, stable health but unable to move their legs or stand. They must have bowel dysfunction due to the injury and certain cardiovascular issues like low blood pressure. Participants should be at least 2 years post-injury and not use nicotine, be pregnant, or have untreated psychiatric disorders.

Inclusion Criteria

I am 18 years old or older.

My spinal cord injury is not getting worse.

I cannot stand up on my own.

I cannot move all the joints in my legs on my own.

I have bowel problems due to a spinal cord injury.

Exclusion Criteria

I have heart or bowel problems not caused by my spinal cord injury.

I rely on a machine to help me breathe.

I have a painful bone/joint issue, unhealed break, or pressure sore that hasn't been treated.

Participant Groups

The study tests if specific spinal cord epidural stimulation can improve bowel function in individuals with spinal injuries. It explores different stimulation methods both with and without standing support to see how they affect bowel control and quality of life.

4Treatment groups

Experimental Treatment

Group I: Epidural stimulation for trunk and core without standExperimental Treatment1 Intervention

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

Group II: Epidural stimulation for trunk and core with standExperimental Treatment1 Intervention

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

Group III: Epidural stimulation for blood pressure without standExperimental Treatment1 Intervention

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

Group IV: Epidural stimulation for blood pressure with standExperimental Treatment1 Intervention

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