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taVNS + Robotic Arm Training for Stroke (VaNSaRTS Trial)
VaNSaRTS Trial Summary
This trial will determine if stimulating the vagus nerve can help improve movement in patients with chronic stroke.
VaNSaRTS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowVaNSaRTS Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.VaNSaRTS Trial Design
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Who is running the clinical trial?
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- You have an implanted device that can be affected by electricity, magnetism, or mechanical forces, such as a pacemaker. Any decision about participants with loop recorders will be made by the principal investigator and the treating cardiologist on a case-by-case basis.I am fully vaccinated and have not had recent cold symptoms or lost my sense of taste or smell.My arm movement is limited but not completely lost.I had a stroke in the upper part of my brain at least 6 months ago, confirmed by MRI or CT.You have metal in your body, such as a metal implant or a metal injury in the eye. Each case will be reviewed individually by the principal investigator to decide if you can participate.I cannot move my shoulders or elbows at all.I do not have serious heart rhythm problems.I am between 18 and 85 years old.I can understand and follow study instructions.I have severe difficulty swallowing.You have previously injured your vagus nerve.I have not had Botox treatment in the last 3 months.I will not start new rehabilitation treatments during the study.I have a permanent bend in my limb that I cannot straighten.I have scars, broken skin, or metal piercings that can't be removed where the device would be used.I have had a fever or cold symptoms recently.
- Group 1: Unaffected limb
- Group 2: Affected Limb
- 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 people are volunteers for this clinical test?
"That is correct, the study detailed on clinicaltrials.gov is currently looking for 45 participants across 1 site. The posting date was March 23rd, 2022 and the most recent edit was on April 13th, 2022."
May I join this clinical trial?
"This particular trial is only open to those who have had a stroke and are between 18-85 years old--45 patients in total will be enrolled."
Does the FDA condone this medication?
"This treatment option appears to be safe according to our analysis, as it is a Phase 2 trial. While there is data supporting the safety of this intervention, there is currently no evidence that it is effective."
Does this experiment allow volunteers of all ages or just those 85 and under?
"This trial includes all patients that are aged 18 or older, with a maximum age limit of 85."
Could you tell me if this research project is still recruiting participants?
"That is correct. Based on the information available online, this clinical trial is currently looking for patients to enroll. The posting date was March 23rd, 2022 and the most recent update was April 13th, 2022. So far, 45 people have signed up at the single location."
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