Manhasset, New York 11030


Purpose:

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.


Study summary:

Promising new animal research suggests that vagus nerve stimulation paired with motor intervention induces movement-specific plasticity in the motor cortex and improves limb function after stroke. These results were recently extended to the first clinical trial, in which patients with stroke demonstrated significant improvements in upper limb function following rehabilitation paired with implanted VNS. Currently, vagus nerve stimulation is being used clinically to treat a number of human diseases including migraine headaches, epilepsy, and depression, and these investigations are expanding to deliver stimulation via a transcutaneous route to potentially improve intervention efficacy and decrease side effects. This pilot study will combine non-invasive transcutaneous stimulation of the vagus nerve with upper limb robotic therapy to investigate the potential of tVNS to augment improvements gained with robotic therapy in patients with chronic hemiparesis after stroke.


Criteria:

Inclusion Criteria: - 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: - Hemorrhagic stroke - 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 - Specific medications that may interfere with acetylcholine and norepinephrine release including muscarinic antagonists, benzodiazepines, selective serotonin reuptake inhibitors, nicotinic antagonists, tricyclic antidepressants, anti-psychotic medications, anti-epileptic medications, and γ-amino butyric acid agonists (enrollment to be determined by PI review) - 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


NCT ID:

NCT03592745


Primary Contact:

Johanna Chang, MS
Phone: 516-562-3646
Email: jchang14@northwell.edu


Backup Contact:

Email: bvolpe1@northwell.edu
Bruce T Volpe, MD
Phone: 516-562-3384


Location Contact:

Manhasset, New York 11030
United States

Johanna Chang, MS
Phone: 516-562-3646
Email: jchang14@northwell.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: February 04, 2019

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