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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 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.

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
1,347 Previous Clinical Trials
650,754 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,847 Previous Clinical Trials
47,818,226 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,719 Previous Clinical Trials
7,511,920 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

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
~1 spots leftby Dec 2024