Epidural Stimulation for Spinal Cord Injury
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new treatment called the Epidural Spinal Cord Stimulation System for individuals with spinal cord injuries. The goal is to determine if this treatment can improve quality of life by addressing issues like arm weakness and problems with automatic body functions, such as blood pressure regulation. Participants should have had a spinal cord injury in the neck area for more than a year, resulting in ongoing arm weakness, and should not require breathing support. The study will compare the effects of the stimulation being turned "on" and "off" over time. As a Phase 1, Phase 2 trial, this research aims to understand how the treatment works and measure its effectiveness in an initial group, offering participants a chance to contribute to groundbreaking advancements in spinal cord injury treatment.
Do I need to stop my current medications for the trial?
The trial does not specify if you need to stop all current medications, but you cannot use antiplatelet/anticoagulation agents around the time of surgery, and certain treatments like botulinum toxin or intrathecal baclofen pump need approval from the study doctor.
What prior data suggests that the Epidural Spinal Cord Stimulation System is safe for spinal injury patients?
Research has shown that the epidural spinal cord stimulation system is generally safe for people. Studies have found that using this system for spinal cord injuries has a safety level similar to its use in treating long-term pain, indicating comparable and accepted risks.
One study found that this system helps manage blood pressure issues in people with spinal cord injuries, reducing the need for additional treatments to control low blood pressure. This suggests the system can be both safe and beneficial.
Overall, the treatment remains under investigation in clinical trials, indicating a need for further research. However, current evidence suggests it is well-tolerated by patients.12345Why do researchers think this study treatment might be promising?
Epidural Spinal Cord Stimulation is unique because it directly targets the spinal cord to restore movement and sensation in spinal cord injury patients. Unlike traditional treatments that rely on physical therapy and medication to manage symptoms, this technique uses electrical stimulation to activate nerve pathways below the injury site. This approach has the potential to improve motor function more significantly and rapidly than existing options, offering hope for enhanced recovery and quality of life for those affected by spinal cord injuries. Researchers are excited because this method may lead to breakthroughs in restoring mobility and autonomy for patients with severe spinal injuries.
What evidence suggests that the Epidural Spinal Cord Stimulation System might be an effective treatment for spinal cord injury?
Research shows that epidural spinal cord stimulation (eSCS) can enhance movement and improve heart and blood pressure functions in individuals with long-term spinal cord injuries. In this trial, participants with cervical spinal cord injuries will compare the effects of eSCS during periods when the stimulation is "on" versus "off." Studies have found that eSCS might enhance movement abilities and help the brain form new connections. Evidence indicates that eSCS can improve voluntary movement control and functions like heart rate and blood pressure. While more research is needed to fully understand and refine this treatment, early results are promising for those with long-term neck-level spinal cord injuries.23567
Who Is on the Research Team?
Nadine Mansour, MD, MPH, PhD
Principal Investigator
University of Minnesota
Manda Keller-Ross, PhD, DPT, PT
Principal Investigator
University of Minnesota
Ann Parr, MD, PhD
Principal Investigator
University of Minnesota
Are You a Good Fit for This Trial?
CE-STAND is for adults over 22 with stable, motor-complete spinal cord injury (SCI) between C4 and C7, who have had the injury for more than a year. Participants must be medically stable, able to attend all appointments, understand the study process, and have normal or corrected vision and hearing.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Implantation and Initial Assessment
The Abbott Eterna epidural stimulator system is implanted, and initial assessments are conducted
Treatment and Optimization
Participants undergo treatment with epidural spinal cord stimulation, with optimization of stimulation settings using Bayesian process
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessments of adverse events and changes in various physiological parameters
What Are the Treatments Tested in This Trial?
Interventions
- Epidural Spinal Cord Stimulation System
Trial Overview
The trial tests an Epidural Spinal Cord Stimulation System on individuals with chronic cervical SCI focusing on autonomic dysfunction. It aims to improve function and quality of life by addressing areas often overlooked in research.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Experimental: Individuals with cervical SCI comparing stimulation "on" vs "off" longitudinally.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Minnesota
Lead Sponsor
Citations
Effect of epidural spinal cord stimulation after chronic spinal ...
The aim of this study is to assess the effects of tonic eSCS after chronic SCI on quantitative outcomes of volitional movement and cardiovascular function.
Epidural Spinal Cord Stimulation for Spinal Cord Injury in ...
This study reviews the evolving role of epidural spinal cord stimulation (eSCS) in treating chronic SCI, focusing on its efficacy and safety.
Long-term Follow-up for Epidural Stimulation in SCI
The goal of this study is to understand long-term effects of spinal cord stimulation in individuals who have a spinal cord injury.
A Review of Functional Restoration From Spinal Cord ...
This review aims to assess the efficacy of spinal cord stimulation, both epidural (eSCS) and transcutaneous (tSCS), on the return of function in individuals ...
Recent advances in potential mechanisms of epidural ...
Epidural spinal cord stimulation shows promise in enhancing motor function and promoting neuroplasticity, but further research is needed to optimize treatment ...
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 ...
An implantable system to restore hemodynamic stability ...
The system durably reduced the severity of hypotensive complications in people with SCI, removed the necessity for conservative treatments, ...
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