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Neuromodulation Techniques for Spinal Cord Injury
Study Summary
This trial is testing if a robotic suit can help people with spinal cord injuries walk, which could help with other health problems associated with the injury.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- You have a pacemaker or defibrillator implanted in your body.I have a severe pressure ulcer on my trunk, pelvis, or legs.You cannot use the device for any reason.I am a man aged 18-70 with a severe spinal cord injury above T10.I have a fracture in my arm or leg that hasn't healed.I have high blood pressure or severe dizziness when standing.I am on blood thinners that I cannot stop for medical reasons.My doctor says my severe muscle stiffness cannot be treated.You will have a test to check your spinal cord function, and only those with severe motor deficits below the level of the injury will be included.Your bone density scan shows that your bones are weaker than normal.I do not have severe heart disease, unmanaged diabetes, high blood pressure, major skin sores, or a serious urinary infection.I have a nerve injury that is not a spinal cord injury but affects my limbs or lower back.I have severe scoliosis or joint issues that prevent me from using an exoskeleton.My muscle stiffness has been checked for safety before starting rehab.My arms and legs have been checked for movement, strength, tightness, and skin health.I have severe muscle stiffness or limited movement.
- Group 1: EAW+TS
- Group 2: EAW+SCES
- 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
How many willing individuals are enrolled in this experiment?
"That is accurate. The information available on clinicaltrials.gov does show that this study is looking for more participants. This trial was first posted on 6/1/2020 and was last updated recently on 4/5/2022. They are only searching for 10 people total at 1 location."
Are there any available openings for participants in this research?
"That is accurate. According to the listings on clinicaltrials.gov, this study began recruiting patients on 6/1/2020 and is still seeking participants. They are looking for a total of 10 individuals at 1 location."
I am interested in enrolling as a subject for this experiment, what are the next steps?
"This trial is seeking 10 individuals that have suffered a spinal cord injury, are aged between 18 and 70, and meet the following requirements: All participants will be between 18-70 years old, male, with traumatic motor complete SCI and level of injury of T10 and above, as determined by EMG testing and International Standards for Neurological Classification of SCI (ISNCSCI) exam, All participants will undergo ISNCSCI examination for neurological level and function and only those with American Spinal Injury Classification (AIS A and B; i.e. motor deficit below the level of injury) will be included."
How does EAW+SCES (exoskeleton and spinal cord epidural stimulation) affect long-term health?
"EAW+SCES (exoskelton and spinal cord epidural stimulation) has not been proven effective yet, but there is some data supporting its safety which puts it at a 2 on our scale."
Does the age limit for this trial exclude people who are under 35 years old?
"In order to be applicable for this study, potential patients must fall in the age bracket of 18-70. There are currently 39 other trials underway testing drugs on individuals below 18 and 324 studies involving those above 65."
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