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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ change from baseline after 4 months, 8 months, 14 months, 20 months.

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

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 8Eligibility criteria met