Paired Non-invasive VNS in Adolescent Cerebral Palsy Rehabilitation

Use of Paired Non-Invasive Vagus Nerve Stimulation in Rehabilitation of Adolescents With Cerebral Palsy: An Open Label Safety Feasibility Trial

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 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)