Epidural Spinal Cord Stimulation for Spinal Cord Injury
(E-STAND Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This study will evaluate a method to optimize parameter settings in epidural spinal cord stimulation used to recover lower extremity volitional movement. The study will also characterize improvement in autonomic function (such as blood pressure control) and other functions related to spinal cord injury.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot take antiplatelet or anticoagulation agents around the time of surgery, and you cannot have a current or anticipated need for opioid pain medications.
Is spinal cord stimulation generally safe for humans?
Spinal cord stimulation is generally considered safe, with rare reports of serious complications like spinal cord injury. The most common issue is equipment failure, and while some risks like infection or dural puncture (a tear in the outer membrane of the spinal cord) exist, they are not common.12345
How is epidural spinal cord stimulation different from other treatments for spinal cord injury?
Epidural spinal cord stimulation (SCS) is unique because it uses electrical impulses to stimulate the spinal cord, which can help restore some motor and sensory functions after a spinal cord injury. Unlike other treatments that may focus solely on pain relief, SCS has shown potential in improving movement and autonomic functions, such as blood pressure regulation, when combined with rehabilitation exercises.678910
What data supports the effectiveness of the treatment Epidural Spinal Cord Stimulation for Spinal Cord Injury?
Research shows that epidural spinal cord stimulation can effectively manage chronic pain in various conditions, such as reflex sympathetic dystrophy and failed back surgery syndrome, with many patients experiencing significant pain relief. Although the studies focus on pain management, the positive outcomes suggest potential benefits for spinal cord injury treatment, especially in carefully selected patients.89111213
Who Is on the Research Team?
David Darrow, MD MPH
Principal Investigator
University of Minnesota
Are You a Good Fit for This Trial?
This trial is for adults over 22 with stable, motor-complete paraplegia due to spinal cord injury between C6 and T10. Participants must have had the injury for over a year, be medically stable, able to consent, and commit to all appointments. Excluded are those with certain health risks or conditions that complicate surgery or rehabilitation.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive epidural spinal cord stimulation to optimize parameter settings for volitional movement and autonomic function
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Epidural Spinal Cord Stimulation
Epidural Spinal Cord Stimulation is already approved in European Union, United States, Canada for the following indications:
- Failed back surgery syndrome
- Complex regional pain syndrome
- Chronic neuropathic pain
- Ischemic pain
- Failed back surgery syndrome
- Complex regional pain syndrome
- Chronic neuropathic pain
- Ischemic pain
- Diabetic neuropathy
- Failed back surgery syndrome
- Complex regional pain syndrome
- Chronic neuropathic pain
- Ischemic pain
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Minnesota
Lead Sponsor
Minnesota Office of Higher Education
Collaborator
Minneapolis Veterans Affairs Medical Center
Collaborator
Hennepin County Medical Center, Minneapolis
Collaborator
Hennepin Healthcare Research Institute
Collaborator