Epidural Stimulation for Spinal Cord Injury
(LTO Trial)
Trial Summary
What is the purpose of this trial?
This study will evaluate the long-term effect of chronic spinal cord stimulation to restore volitional movement for patients with chronic spinal cord injuries.
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 participate if you need opioid pain medications or have used Botox in the last six months.
What data supports the effectiveness of the treatment Epidural Spinal Cord Stimulation for Spinal Cord Injury?
Research shows that epidural spinal cord stimulation can improve physical function after spinal cord injury and has been effective in managing chronic pain conditions, such as reflex sympathetic dystrophy and pain from failed back surgery. It has also been used successfully for neuropathic pain and vascular-linked pain, indicating its potential for broader applications.12345
Is epidural stimulation generally safe for humans?
How does epidural spinal cord stimulation differ from other treatments for spinal cord injury?
Epidural spinal cord stimulation is unique because it involves placing electrodes on the spinal cord to send electrical signals, which can help improve movement and reduce pain in people with spinal cord injuries. Unlike other treatments, it directly targets the spinal cord to facilitate posture and locomotion, and it has shown promise in helping patients regain some ability to stand or step.45111213
Research Team
David Darrow, MD MPH
Principal Investigator
University of Minnesota
Eligibility Criteria
This trial is for adults over 22 with stable spinal cord injuries, who are not ventilator-dependent and have an existing, working FDA-approved spinal cord stimulator. They should be medically stable and at least a year out from their initial injury. Those with certain levels of impairment (AISA 'A' or 'B'), no recent Botox treatments, and not on opioid pain meds that would limit rehab participation can join.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive chronic spinal cord stimulation to restore volitional movement
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
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