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Device

Epidural Stimulation for Spinal Cord Injury

N/A
Recruiting
Led By Susan Harkema, PhD
Research Sponsored by University of Louisville
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate bladder training
AIS classification A or B
Must not have
Continent diversion procedures with or without bladder augmentation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Summary

This trial will help researchers determine the best way to use electrical stimulation of the spinal cord to improve bladder function in people with spinal cord injuries.

Who is the study for?
This trial is for individuals with stable spinal cord injuries (SCI) who are at least two years post-injury, have an implanted epidural stimulator, and show signs of recovery from spinal shock. It's not suitable for those with certain medical conditions, ongoing drug abuse, recent bladder treatments like Botox injections or surgeries that change the way urine leaves the body.Check my eligibility
What is being tested?
The study tests how different settings on a 16-electrode epidural device affect bladder control in people with SCI. The goal is to find out which settings improve bladder function during storage and voiding by activating specific spinal circuits.See study design
What are the potential side effects?
While the description doesn't specify side effects, generally epidural stimulation can cause discomfort at the stimulation site, potential skin irritation from electrodes, or changes in blood pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My heart and lung health allows me to undergo bladder training.
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My spinal cord injury is classified as complete or sensory incomplete.
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My spinal shock has ended, shown by muscle tone or reflexes, and I've finished standard rehab.
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It has been over 2 years since my spinal cord injury.
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My spinal cord injury is above the sacrum and not worsening.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had surgery to redirect urine flow with or without bladder enlargement.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Changes in bladder volume during filling cystometry at low filling pressures
Secondary outcome measures
Changes in Bowel Function
Changes in Sexual Function
Changes in Systolic Blood Pressure
Other outcome measures
Changes in Renal Bladder Ultrasound

Trial Design

1Treatment groups
Experimental Treatment
Group I: Bladder Mapping and TrainingExperimental Treatment1 Intervention
Individuals already implanted or newly implanted with a spinal cord epidural stimulator will receive epidural stimulation targeted at enhancing both the storage and voiding phase of micturition cycle.

Find a Location

Who is running the clinical trial?

National Institute of Neurological Disorders and Stroke (NINDS)NIH
1,349 Previous Clinical Trials
648,167 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,854 Previous Clinical Trials
47,817,862 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,736 Previous Clinical Trials
7,507,940 Total Patients Enrolled

Media Library

Epidural Stimulation (Device) Clinical Trial Eligibility Overview. Trial Name: NCT03452007 — N/A
Spinal Cord Injury Research Study Groups: Bladder Mapping and Training
Spinal Cord Injury Clinical Trial 2023: Epidural Stimulation Highlights & Side Effects. Trial Name: NCT03452007 — N/A
Epidural Stimulation (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03452007 — N/A
~1 spots leftby Dec 2024
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