Epidural Stimulation for Spinal Cord Injury
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether an implanted epidural stimulator (a device placed in the spine) can help people with spinal cord injuries regain voluntary movement. Researchers are testing if MRI scans, which reveal spared neural fibers in the spinal cord, can help select participants who might benefit from this treatment. The trial includes intensive physical therapy to assist with leg movement while the stimulator is active. It seeks participants who have had a spinal cord injury for over six months, have remaining neural fibers, and can use a stability aid with their upper body. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could lead to new treatments for spinal cord injuries.
What prior data suggests that this implanted epidural stimulator is safe for spinal cord injury patients?
Research has shown that epidural stimulation, a treatment for spinal cord injuries, is generally safe. Studies have found that this treatment can improve movement and automatic body functions without major safety issues. For example, one study found that the safety of epidural stimulation for spinal cord injuries is similar to its use in treating chronic pain, indicating it is well-tolerated.
In another study, most patients reported good to very good results, with benefits including improved movement and function in affected areas. While any procedure carries potential risks, the evidence so far suggests that epidural stimulation is a promising option for those with spinal cord injuries.12345Why are researchers excited about this trial?
Researchers are excited about epidural stimulation for spinal cord injury because it offers a unique approach to restoring voluntary movement. Unlike current treatments, which often focus on managing symptoms or using extensive rehabilitation alone, this method uses an implanted epidural stimulator that actively facilitates movement by delivering electrical impulses to the spinal cord. This stimulation, combined with intensive physical therapy, aims to optimize voluntary control over movements like ankle, knee, and hip flexion and extension. This approach could significantly improve mobility and independence for individuals with spinal cord injury, which is a game-changer compared to traditional therapies.
What evidence suggests that this implanted epidural stimulator is effective for spinal cord injury?
Research has shown that epidural stimulation can help people with spinal cord injuries regain movement. In studies, 87% of participants experienced improved muscle activity, and 65% could walk faster. Another study found that this treatment enhanced voluntary movement and muscle strength, with many patients also experiencing better walking ability. Overall, epidural stimulation has improved quality of life by helping restore lost functions. Participants in this trial will receive epidural stimulation combined with intensive physical therapy to optimize voluntary control of lower extremity movements.12367
Who Is on the Research Team?
Andrew C Smith, PT, DPT, PhD
Principal Investigator
University of Colorado, Denver
Are You a Good Fit for This Trial?
This trial is for adults with a spinal cord injury between the C7 and T8 levels, diagnosed as AIS B, who are at least 6 months post-injury. Participants must be between 5'1" and 6'3", weigh no more than 250 lbs, have some upper body strength to use a stability aid, and show spared neural fibers on MRI.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive epidural stimulation and intensive outpatient physical therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Implanted Epidural Stimulator
Trial Overview
Researchers are testing whether surgically implanting an epidural stimulator can help restore voluntary movement in people with certain spinal cord injuries. Only two participants will be selected based on MRI results showing preserved nerve fibers.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Stimulation parameters will be optimized for each lower extremity and joint movement. During physical therapy sessions, electrode configurations may be adjusted as needed to optimize stimulation frequencies, and voltage intensity ranges to best enable voluntary control of lower extremity (ankle, knee, and hip) flexion and extension, as well as standing. Intensive physical therapy will consist of 3 visits per week over the course of 6 months directed by a licensed physical therapist with over a decade of experience working with individuals with spinal cord injury, and the epidural stimulator will be ON continuously during these sessions. Physical therapy will involve neurorehabilitation to facilitate voluntary lower extremity movement in the presence of stimulation, with the research participants in the supine, seated, and standing positions.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Colorado, Denver
Lead Sponsor
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
Citations
Spinal cord epidural stimulation for motor and autonomic ...
scES in this series was safe and achieved numerous benefits on motor and cardiovascular regulation and improved patient-reported QOL in multiple domains.
NCT02592668 | Spinal Cord Injury Epidural Stimulation
This is a feasibility study to test the use of epidural stimulation to restore volitional function previously lost due to spinal cord injury.
Epidural Spinal Cord Stimulation for Spinal Cord Injury in ...
87% showed enhanced muscle activity; 65% experienced faster walking speeds; and 80% improved in overground walking.
Spinal Cord Injury Epidural Stimulation
Epidural electrical stimulation (EES) of the spinal cord has been shown to restore function after spinal cord injury (SCI).
Epidural Stimulation Treatment for Spinal Cord Injury
results differ from person to person and the outcome varies. Our current patients have experienced: Voluntary movement in affected muscles. Improved strength ...
The safety of epidural spinal cord stimulation to restore ...
Conclusions: eSCS to restore autonomic and volitional motor function following SCI has a similar safety profile as when used to treat chronic pain, despite the ...
A case study of percutaneous epidural stimulation to ...
Two persons with chronic motor complete spinal cord injury (SCI) were implanted with percutaneous spinal cord epidural stimulation (SCES) leads to enable motor ...
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