Overview
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
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)
