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Device
taVNS + Robotic Arm Training for Stroke (VaNSaRTS Trial)
Phase 2
Recruiting
Led By Bruce T Volpe, MD
Research Sponsored by Northwell Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
In receipt of full vaccination status and no recent upper respiratory symptoms and no loss of taste or olfaction
Fugl-Meyer assessment 12 to 44 out of 66 (neither hemiplegic nor fully recovered motor function in the muscles of the shoulder, elbow, and wrist)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 30-45minutes
Awards & highlights
VaNSaRTS Trial Summary
This trial will determine if stimulating the vagus nerve can help improve movement in patients with chronic stroke.
Who is the study for?
This trial is for adults aged 18-85 who've had a single stroke at least 6 months ago, with some arm movement but not fully recovered. They must be vaccinated, have no recent respiratory issues or taste/smell loss, and can't be pregnant or breastfeeding. People with vagus nerve damage, severe swallowing difficulties, certain implants, metal injuries to the eye or arrhythmias are excluded.Check my eligibility
What is being tested?
The study tests if taVNS (a non-invasive ear stimulation) combined with robotic training helps improve arm function in chronic stroke patients. Participants will use an In Motion Rehabilitation Robot while receiving taVNS to see if it enhances motor recovery compared to robot training alone.See study design
What are the potential side effects?
Potential side effects of taVNS may include discomfort at the stimulation site, headache, lightheadedness and skin irritation. The robotic training is generally safe but might cause muscle soreness due to repetitive movements.
VaNSaRTS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am fully vaccinated and have not had recent cold symptoms or lost my sense of taste or smell.
Select...
My arm movement is limited but not completely lost.
Select...
I had a stroke in the upper part of my brain at least 6 months ago, confirmed by MRI or CT.
Select...
I am between 18 and 85 years old.
Select...
I can understand and follow study instructions.
VaNSaRTS Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 30-45minutes
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30-45minutes
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Fugl-Meyer Motor Scale for the upper extremity
Secondary outcome measures
Action Research Arm Test (ARAT)
VaNSaRTS Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Unaffected limbActive Control1 Intervention
Patients will engage the robot first with their unaffected limb. This practice will ensure understanding and serve to activate the hemisphere ipsilateral to the impaired limb. Patients are likely to perform this activity quickly, there will not be any taVNS during this part of the procedure.
Group II: Affected LimbPlacebo Group1 Intervention
Patients will wear the taVNS device on the left ear for the duration of the subsequent phase of the robotic training. During this phase the patient will engage the robotic device with the affected limb and complete the protocol and the stimulation or sham stimulation will occur with every extensor movement.
Within subject. Sham controlled. Double blind, the patient will not know whether they are receiving taVNS, all patients feel a ramp up current but only the active group will receive timed stimulation bursts during the robotic protocol that engages the affected limb. '
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Who is running the clinical trial?
Northwell HealthLead Sponsor
458 Previous Clinical Trials
470,888 Total Patients Enrolled
11 Trials studying Stroke
343 Patients Enrolled for Stroke
Timir Datta Chaudhuri, PhDStudy DirectorFeinstein Center for Bioelectronic Medicine
Bruce T Volpe, MDPrincipal InvestigatorFeinstein Center for Molecular Medicine
4 Previous Clinical Trials
106 Total Patients Enrolled
4 Trials studying Stroke
106 Patients Enrolled for Stroke
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- 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.
Research Study Groups:
This trial has the following groups:- Group 1: Unaffected limb
- Group 2: Affected Limb
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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."
Answered by AI
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