Trans Auricular Vagus Nerve Stimulation (taVNS) and Robotic Training for Paralyzed Arm After Stroke

Status unconfirmed · Phase 2 · Has a placebo group

Conditions studied: Stroke, Hemiparesis

In brief

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.

Key facts

Study ID

NCT05339893

Run by

Northwell Health

People needed

45

Starts

2022-03-23

Expected to finish

2025-04-18

Last updated by the study team

2023-04-21

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• Feinstein Institutes at Northwell Health — Manhasset, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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