Paired Non-invasive VNS in Adolescent Cerebral Palsy Rehabilitation

Recruiting now · Not applicable

Conditions studied: Cerebral Palsy

In brief

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.

Key facts

Study ID

NCT07394608

Run by

Icahn School of Medicine at Mount Sinai

People needed

10

Starts

2026-04-01

Expected to finish

2028-03-01

Last updated by the study team

2026-03-13

Who can join

Age: 12 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• The Charles Lazarus Children's Abilities Center — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.