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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

Sponsor: Icahn School of Medicine at Mount Sinai · Participants: 10 · Started: 2026-04

Contact the study team

Official record on ClinicalTrials.gov — NCT07394608

Locations in the U.S.

New YorkThe 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.