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Epidural Stimulation + Resistance Training for Spinal Cord Injury (REST-SCI Trial)
REST-SCI Trial Summary
This trial is investigating whether adding 6 months of resistance training to epidural stimulation and assisted walking can help people with spinal cord injuries to recover motor control, improve cardiovascular health, and regain bladder control.
REST-SCI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowREST-SCI Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.REST-SCI Trial Design
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Who is running the clinical trial?
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- You cannot physically fit into the device for any reason.You have a history of mental health issues that could interfere with the study goals.I have a severe pressure ulcer.My arms and legs have been checked for movement, strength, tightness, and skin health.I am 18-60 years old with a spinal cord injury above T10, confirmed by tests.My leg muscles respond to electrical stimulation after my spinal cord injury.I have a spinal injury classified as AIS A or B with motor issues below the injury.I have high blood pressure that isn't managed or severe dizziness when standing up.My doctor says my severe muscle stiffness cannot be treated.I do not have severe scoliosis or joint issues that prevent me from using an exoskeleton.I have a fracture in my arm or leg that hasn't healed.My spinal cord injury is severe, above T10, and confirmed by tests.You have a pacemaker or defibrillator implanted in your body.I am between 18 and 60 years old.My leg muscles respond to a specific nerve stimulation test after my spinal cord injury.I am on blood thinners that I cannot stop for medical reasons.Your bone density test shows your bones are very weak.I do not have severe heart disease, unmanaged diabetes, high blood pressure, major skin sores, or a serious urinary infection.I have a neurological injury that affects my limbs or lower back, not caused by spinal cord injury.I have a spinal injury classified as AIS A or B, showing motor deficit below the injury level.
- Group 1: EAW+ES+RT
- Group 2: EAW+ delayed-ES +no-RT
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
If I meet the requirements, may I sign up for this research project?
"This study is willing to enroll 20 participants that have spinal cord injuries and are between 18-60 years old."
Are elders welcome to participate in this clinical trial?
"This particular clinical trial is for patients aged 18-60, though there are 39 trials specifically for minors and 323 trials for senior citizens."
Are there any empty slots in this clinical trial for patients who want to participate?
"Yes, that is correct. The clinical trial in question was posted on February 3rd 2021 and updated February 2nd of this year. They are looking for a total of 20 patients from a single location."
How many total people can join this clinical trial?
"That is right, the details available on clinicaltrials.gov show that this trial is currently looking for volunteers. The listing was first put up on February 3rd, 2021 and was updated most recently on February 2nd, 2022. They need 20 individuals total from 1 site."
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