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
Conditions
Cerebral Palsy
Locations
The Charles Lazarus Children's Abilities Center
New York, New York 10029
United States