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Neurostimulation Device
Spinal Cord Epidural Stimulation for Spinal Cord Injury
N/A
Recruiting
Led By Charles Hubscher, 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
Arm 1: Neurogenic bladder and bowel dysfunction
Arm 2: Neurogenic bladder and bowel dysfunction
Must not have
Arms 1 and 2: Prior Botox injections of the bladder and/or bladder augmentation surgery
Arms 1 and 2: Colostomy bag
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 80 sessions (6 months)
Awards & highlights
No Placebo-Only Group
Summary
This trial will study how well a new treatment for autonomic dysreflexia works in people with spinal cord injuries.
Who is the study for?
This trial is for adults with spinal cord injuries who have issues with bladder and bowel control. Participants must use intermittent catheterization and not be pregnant, ventilator-dependent, or have a colostomy bag. They shouldn't have had certain bladder treatments like Botox injections or surgery.
What is being tested?
The study tests how well spinal cord epidural stimulation can manage high blood pressure and improve bladder and sexual function after injury. It involves controlled lab assessments and at-home monitoring to evaluate the therapy's effectiveness.
What are the potential side effects?
Potential side effects may include discomfort at the stimulation site, changes in blood pressure during stimulation, skin irritation from electrodes, headache, back pain, or unexpected impacts on bladder or bowel functions.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have issues controlling my bladder and bowel due to nerve problems.
Select...
I have issues controlling my bladder and bowel due to nerve problems.
Select...
I am 18 years old or older.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have had Botox injections in my bladder or bladder surgery before.
Select...
I use a colostomy bag.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 80 sessions (6 months)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 80 sessions (6 months)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from baseline in systolic blood pressure over a 24 hour period after 80 sessions (6 months)
Secondary study objectives
Change from baseline in bladder capacity after 80 sessions (6 months)
Change from baseline in detrusor pressure after 80 sessions (6 months)
Change from baseline in mean resting anal pressure after 80 sessions (6 months)
+1 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Cardiovascular spinal cord epidural stimulationExperimental Treatment1 Intervention
The purpose of this arm is to use spinal cord epidural stimulation for maintenance of blood pressure and heart rate in the lab during cystometry (bladder filling) and anorectal filling (bowel distension) and in the at-home setting for maintenance of normative blood pressure and heart rate that can be triggered from bladder filling and during bowel evacuation.
Group II: Measure symptomatic indices of autonomic dysreflexiaActive Control1 Intervention
The purpose of this arm is to systematically measure symptomatic indices of autonomic nervous system activation and corresponding cardiovascular changes in persons with spinal cord injuries during bladder filling and bowel stimulation.
Find a Location
Who is running the clinical trial?
University of LouisvilleLead Sponsor
348 Previous Clinical Trials
77,308 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,840 Previous Clinical Trials
8,172,553 Total Patients Enrolled
Charles Hubscher, PhDPrincipal Investigator - University of Louisville
University of Louisville
1 Previous Clinical Trials
6 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You need to use a ventilator to help you breathe for Arms 1 and 2.You have had a Medtronic scES array implanted before.I have had Botox injections in my bladder or bladder surgery before.I have issues controlling my bladder and bowel due to nerve problems.I use a catheter sometimes to help empty my bladder.I have issues controlling my bladder and bowel due to nerve problems.You have any type of implanted pump in your body, like a Baclofen pump or a pain pump.I use a colostomy bag.I am 18 years old or older.My spinal cord injury is classified between AIS A to D.I am 18 years old or older.My health condition is stable.My spinal cord injury is classified between AIS A to D.
Research Study Groups:
This trial has the following groups:- Group 1: Measure symptomatic indices of autonomic dysreflexia
- Group 2: Cardiovascular spinal cord epidural stimulation
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.