๐ฌIn plain words
What the trial is, and whether it could suit you
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.
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
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)
The Charles Lazarus Children's Abilities Center
New York, United States
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.