Trans Auricular Vagus Nerve Stimulation (taVNS) and Robotic Training for Paralyzed Arm After Stroke (NCT05339893) | Clinical Trial Compass
UnknownPhase 2
Trans Auricular Vagus Nerve Stimulation (taVNS) and Robotic Training for Paralyzed Arm After Stroke
United States45 participantsStarted 2022-03-23
Plain-language 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 motor impairment.
Who can participate
Age range18 Years – 85 Years
SexALL
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Inclusion Criteria:
* 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 Criteria:
* 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…