Transcutaneous Vagus Nerve Stimulation (tVNS) and Robotic Training to Improve Arm Function After Stroke

Completed · Phase 2 · Has a placebo group

Conditions studied: Stroke, Cerebrovascular Accident (CVA), Hemiparesis

In brief

The purpose of this study is to evaluate if multiple therapy sessions of Transcutaneous Vagus Nerve Stimulation (tVNS) combined with robotic arm therapy lead to a greater functional recovery in upper limb mobility after stroke than that provided by robotic arm therapy in a sham stimulation condition.

Key facts

Study ID

NCT03592745

Run by

Northwell Health

People needed

36

Starts

2018-08-09

Expected to finish

2021-06-01

Last updated by the study team

2021-06-29

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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…

• 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 Institute for Medical Research — Manhasset, New York, United States

Full record on ClinicalTrials.gov

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