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Spinal Cord Stimulation for Stroke Recovery
Study Summary
This trial is testing whether electrical stimulation of the spinal cord can help people with paralysis in one arm recover movement. A device is implanted to deliver the stimulation, and then removed after a month.
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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- I had a stroke over 6 months ago that affected my arm's movement.I am mentally capable of understanding and signing a consent form.I am between 21 and 70 years old.I do not have any serious illness or cognitive issues that would prevent me from participating in the study.I am taking medication for blood clots, muscle spasms, or seizures during the study.You have a strong fear of being in small or enclosed spaces.My joint stiffness is too severe to do study activities.Your Fugl-Meyer scale score is not between 7 and 50.
- Group 1: Epidural electrical stimulation of the cervical spinal cord
- 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
Are there vacancies available for participants in this trial?
"Affirmative. According to clinicaltrials.gov, this research effort is actively recruiting participants with its first posting on March 24th 2021 and most recent update on August 11th 2022. The trial requires 15 patients from one site."
How many individuals are currently taking part in the experiment?
"Affirmative. According to the research posted on clinicaltrials.gov, this medical investigation is still seeking volunteers and began recruiting on March 24th 2021. The most recent update was issued August 11th 2022 and 15 participants are needed at a single location."
What aspirational objectives has this research endeavor set out to accomplish?
"As the primary outcome, this medical trial will assess evoked motor responses in arm muscles through surface electromyography (EMG) over a 4-week period. As secondary outcomes, examiners will look into sensory motor integration using the KINARM robot; evaluate impairment levels with Fugl-Meyer Assessment scores; and measure spinal circuit excitability via H-reflexes of arm muscles pre and post implantation. Ultimately, it is anticipated that these measures can demonstrate how Spinal cord Stimulation affects sensori-to-motoneuron excitability."
Am I qualified to partake in this research?
"This medical trial seeks 15 volunteers between the ages of 21 and 70 who are afflicted with a central nervous system disorder. Additionally, they must have had either an ischemic or hemorrhagic stroke more than 6 months prior to enrollment which has caused hemiparesis. The Fugl-Meyer scale should also produce scores that range from 7 up to 45 in order for them to be eligible."
Are participants aged 50 or older being included in this trial?
"Patients aged 21 to 70 are qualified for this investigation. Those younger than 18 and older than 65 can still participate in 145 clinical trials and 1513 studies respectively."
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