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Paired Non-invasive VNS in Adolescent Cerebral Palsy Rehabilitation
Recruiting
Use of Paired Non-Invasive Vagus Nerve Stimulation in Rehabilitation of Adolescents With Cerebral Palsy: An Open Label Safety Feasibility Trial
Who can join
Ages 12 to 17 · All sexes
Full eligibility criteria
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)
About the study
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.
What is being tested
- Non-invasive taVNS (device)
Sponsor: Icahn School of Medicine at Mount Sinai · Participants: 10 · Started: 2026-04
Contact the study team
- Jenna Tosto Mancuso, PT, DPT,NCS · Phone: 212-241-8454
Official record on ClinicalTrials.gov — NCT07394608
Locations in the U.S.
| New York | The Charles Lazarus Children's Abilities Center, New York |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.