Epidural Stimulation + Training for Spinal Cord Injury
(MC-PP-3 Trial)
Trial Summary
What is the purpose of this trial?
The loss of movement and walking ability significantly affects quality of life after spinal cord injury. In addition, bladder dysfunction consistently ranks as one of the top disorders affecting quality of life after spinal cord injury. The overall objective of this study is to demonstrate that epidural stimulation may be a method for improving stepping, standing and bladder function in individuals with spinal cord injury. With the use of epidural stimulation, the investigators propose to investigate how well the participant can stand and walk and how well the participant's bladder can store or hold urine as well as void or empty urine. The results of this study may aid in the development of treatments to help individuals with spinal cord injuries that are unable to stand or walk and have impaired bladder function.
Will I have to stop taking my current medications?
The trial requires that participants are not on any current anti-spasticity medication regimen and must not have received botox injections in the prior six months. Other medications are not specified, so it's best to discuss with the trial team.
What data supports the effectiveness of the treatment Epidural Stimulation + Training for Spinal Cord Injury?
Research shows that spinal cord epidural stimulation (scES) can improve bladder control and reflexive voiding efficiency in individuals with spinal cord injury. Additionally, scES has been associated with improvements in motor function and body composition, suggesting its potential to enhance multiple body functions.12345
How does the treatment Epidural Stimulation + Training for Spinal Cord Injury differ from other treatments?
This treatment is unique because it uses electrical stimulation directly on the spinal cord to improve functions like bladder control and mobility, which is different from traditional therapies that may not directly target the spinal cord. It combines this stimulation with specific training exercises to enhance recovery, offering a novel approach to managing spinal cord injury effects.13467
Eligibility Criteria
This trial is for adults over 18 with a stable, non-progressive spinal cord injury (SCI) between T1 and T10. They must be within one year post-injury, unable to stand or walk independently, have bladder dysfunction due to SCI, and not on anti-spasticity meds or received botox in the last six months. Excluded are those ventilator-dependent, with untreated major health issues or psychiatric disorders/drug abuse.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Bladder Training
Participants receive 80 sessions of bladder training with epidural stimulation
Locomotor Training
Participants receive 160 locomotor training sessions with epidural stimulation
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Epidural stimulation + Bladder Capacity Training (Procedure)
- Epidural stimulation + Bladder Voiding Efficiency Training (Procedure)
- Epidural stimulation + Stand Training (Procedure)
- Epidural stimulation + Step Training (Procedure)
Epidural stimulation + Bladder Capacity Training is already approved in Canada for the following indications:
- Spinal cord injury rehabilitation
- Chronic pain management
Find a Clinic Near You
Who Is Running the Clinical Trial?
Susan Harkema PhD
Lead Sponsor
University of Louisville
Lead Sponsor
National Institute of Neurological Disorders and Stroke (NINDS)
Collaborator