Icahn School of Medicine at Mount Sinai
This is an open-label safety and feasibility trial evaluating the use of paired non-invasive vagus nerve stimulation (VNS) and upper extremity (UE) rehabilitation in the motor impairment reduction of adolescent patients with spastic cerebral palsy.
Inclusion criteria: * Age 12-17 years old * Diagnosis of spastic cerebral palsy * Gross Motor Function Classification System (GMFCS) Level II-III (will be evaluated at screening) * Jebsen Taylor Hand Function Test Score of \<37.08 on the affected side at time of screening visit (will be evaluated at screening) * Ability to communicate and follow two step commands at the time of screening * Ability to provide assent as detailed in consent form and based on assessment using the University of California, San Diego Brief Assessment of Capacity to Consent Exclusion criteria: * Previous vagus ner…
Device activates the vagus through the ear. The device is controlled via the Vagustim mobile app, which connects using Bluetooth Low Energy (BLE).
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