Status:
UNKNOWN
Trans Auricular Vagus Nerve Stimulation (taVNS) and Robotic Training for Paralyzed Arm After Stroke
Lead Sponsor:
Northwell Health
Conditions:
Stroke
Hemiparesis
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
To determine whether treatment with transauricular vagus nerve stimulation (taVNS) during the training of an affected upper limb of a patient with chronic stroke on a robotic motor task alters the mot...
Detailed Description
The investigators will evaluate whether transauricular vagus nerve stimulation (taVNS) delivered during extensor movements executed on a robotic device will alter the clinical measurement of upper lim...
Eligibility Criteria
Inclusion
- In receipt of full vaccination status and no recent upper respiratory symptoms and no loss of taste or olfaction.
- Individuals between 18 and 85 years of age
- First single focal unilateral supratentorial ischemic stroke with diagnosis verified by brain imaging (MRI or CT scans) that occurred at least 6 months prior
- Cognitive function sufficient to understand the experiments and follow instructions (per interview with Speech Pathologist or PI)
- 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).
Exclusion
- Recent fever or upper respiratory symptoms.
- Botox treatment within 3 months of enrollment
- Fixed contraction deformity in the affected limb
- Complete and total flaccid paralysis of all shoulder and elbow motor performance
- Prior injury to the vagus nerve
- Severe dysphagia
- Introduction of any new rehabilitation interventions during study
- Individuals with scar tissue, broken skin, or irremovable metal piercings that may interfere with the stimulation or the stimulation device
- Highly conductive metal in any part of the body, including metal injury to the eye; this will be reviewed on a case by case basis for PI to make a determination
- Pregnant or plan on becoming pregnant or breastfeeding during the study period
- Significant arrhythmias, including but not limited to, atrial fibrillation, atrial flutter, sick sinus syndrome, and A-V blocks (enrollment to be determined by PI review)
- Presence of an electrically, magnetically or mechanically activated implant (including cardiac pacemaker), an intracerebral vascular clip, or any other electrically sensitive support system; Loop recorders will be reviewed on a case by case basis by PI and the treating Cardiologist to make a determination
Key Trial Info
Start Date :
March 23 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 18 2025
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT05339893
Start Date
March 23 2022
End Date
April 18 2025
Last Update
April 21 2023
Active Locations (1)
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1
Feinstein Institutes at Northwell Health
Manhasset, New York, United States, 11030