Paired Non-invasive VNS in Adolescent Cerebral Palsy Rehabilitation

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)