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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study 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 belowSelect...
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
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 capacity as assessed by urodynamics
Changes in bladder pressure as assessed by urodynamics
Changes in voiding efficiency as assessed by urodynamics
Secondary outcome measures
Changes in gastrointestinal motility
Changes in rectal squeeze pressure
Trial Design
1Treatment groups
Experimental Treatment
Group I: Bladder Mapping and TrainingExperimental Treatment1 Intervention
Individuals already 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
1,340 Previous Clinical Trials
649,354 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,836 Previous Clinical Trials
47,851,038 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,697 Previous Clinical Trials
7,492,309 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My heart and lung health allows me to undergo bladder training.I have had surgery to redirect urine flow with or without bladder enlargement.I don't have any unhealed injuries or infections that could affect my participation.My spinal cord injury is classified as complete or sensory incomplete.My spinal shock has ended, shown by muscle tone or reflexes, and I've finished standard rehab.It has been over 2 years since my spinal cord injury.My spinal cord injury is above the sacrum and not worsening.I have had bladder Botox injections in the last year.
Research Study Groups:
This trial has the following groups:- Group 1: Bladder Mapping and Training
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the current recruitment capacity for this experimental program?
"Affirmative. Clinicaltrials.gov's data suggests that this clinical trial is actively seeking participants, with its original posting date being September 12th 2018 and last edited on April 26th 2022. The study needs to enroll 10 individuals from a single medical centre."
Answered by AI
Is this research recruiting participants at the present time?
"At present, this medical trial is open to enrollment. It was initially announced on September 12th 2018 and the associated clinicaltrials.gov page has been updated most recently on April 26th 2022."
Answered by AI
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