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NCT07394608NARecruiting

Paired Non-invasive VNS in Adolescent Cerebral Palsy Rehabilitation

Icahn School of Medicine at Mount Sinai

Start Date

4/1/2026

Completion Date

3/1/2028

Summary

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.

Eligibility Criteria

Age Range: 12 years to 17 years

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 nerve injury * Less than 12 years old or greater than 18 years old * History of left or bilateral vagotomy * Current use of other implanted stimulation devices including but not limited to pacemaker, deep brain stimulator, implanted vagus nerve stimulators, cochlear implants, implantable cardiac defibrillators (ICDs)etc. * Current use of any investigational devices or investigational drugs not otherwise specified - Past Medical History for any of the following: * Acute suicidal thinking or behavior * History of schizophrenia, schizoaffective disorder, or delusional disorders * History of rapid cycling bipolar disorder * Progressive neurological diseases * Cardiac arrhythmias or other abnormalities * History of dysautonomia including but not limited to orthostatic hypotension, postural orthostatic tachycardia syndrome, vasovagal syncope etc. * GMFCS score of less than II or greater than 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)

Interventions

DEVICE

Non-invasive taVNS

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Conditions

Cerebral Palsy

Locations

The Charles Lazarus Children's Abilities Center

New York, New York 10029

United States