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Paired Non-invasive VNS for Adolescent Cerebral Palsy

This study is testing a new way to help adolescents (ages 12-17) with spastic cerebral palsy improve their arm and hand movement. It combines a device called non-invasive taVNS (transcutaneous auricular Vagus Nerve Stimulation), which activates a nerve through the ear using a mobile app, with upper body rehabilitation. The main goal is to see if this treatment is safe and practical, by tracking any side effects over 12 months. You might be able to join if you have spastic cerebral palsy, can follow two-step commands, and meet specific criteria for your motor function. This is a small study, planning to enroll 10 participants, and is currently unclear on its recruitment status.

Study design
This is an open-label study, meaning everyone knows what treatment is being given. It's a small study, planning to include 10 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your safety will be monitored for 12 months after the treatment.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07394608

Paired Non-invasive VNS in Adolescent Cerebral Palsy Rehabilitation

Recruiting
NAAges 12–17Interventional
Icahn School of Medicine at Mount Sinai
~10 participants
Updated 2026-03-13 on ClinicalTrials.gov
What's tested:Non-invasive taVNS

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of adverse event and serious adverse events
Measured over 12 months

Conditions

Cerebral Palsy

Explore related trials

Cerebral Palsy

Where it's being run

1 sites across 1 states
New York1

Study leadership

  • David Putrino, PhD · PRINCIPAL_INVESTIGATOR · Icahn School of Medicine at Mount Sinai

Who to contact

Jenna Tosto Mancuso, PT, DPT,NCS
[email protected]
212-241-8454
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Number of adverse event and serious adverse events12 months

    Safety is assessed by adverse event.