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Electrical Stimulation

Spinal Cord Stimulation for Neurogenic Bowel Due to Spinal Cord Injury

N/A
Recruiting
Research Sponsored by University of Louisville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 18 years of age at the time of enrollment
Non-progressive spinal cord injury
Must not have
Cardiovascular or bowel dysfunction unrelated to SCI
Ventilator dependent
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline after 4 months, 8 months, 14 months, 20 months.
Awards & highlights

Summary

This trial is testing whether a certain type of spinal cord stimulation can help improve bowel function for people with spinal cord injuries, which often leads to impaired quality of life.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects are not explicitly listed but may include discomfort from the stimulation process, possible skin irritation where electrodes are placed, and varying responses in blood pressure during treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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My spinal cord injury is not getting worse.
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I cannot stand up on my own.
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I cannot move all the joints in my legs on my own.
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I have bowel problems due to a spinal cord injury.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have heart or bowel problems not caused by my spinal cord injury.
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I rely on a machine to help me breathe.
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I have a painful bone/joint issue, unhealed break, or pressure sore that hasn't been treated.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline after 4 months, 8 months, 14 months, 20 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and change from baseline after 4 months, 8 months, 14 months, 20 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Ambulatory blood pressure and heart rate monitoring
Anorectal Manometry (ARM)
Bowel Diary
+4 more

Trial Design

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

Find a Location

Who is running the clinical trial?

University of LouisvilleLead Sponsor
342 Previous Clinical Trials
77,297 Total Patients Enrolled

Media Library

Stimulation for blood pressure without stand (Electrical Stimulation) Clinical Trial Eligibility Overview. Trial Name: NCT03949660 — N/A
Neurogenic Bowel Research Study Groups: Epidural stimulation for blood pressure without stand, Epidural stimulation for trunk and core without stand, Epidural stimulation for blood pressure with stand, Epidural stimulation for trunk and core with stand
Neurogenic Bowel Clinical Trial 2023: Stimulation for blood pressure without stand Highlights & Side Effects. Trial Name: NCT03949660 — N/A
Stimulation for blood pressure without stand (Electrical Stimulation) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03949660 — N/A
~5 spots leftby Sep 2025
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