NCT07394608 · Icahn School of Medicine at Mount Sinai
Paired Non-invasive VNS in Adolescent Cerebral Palsy Rehabilitation
What this study is about
This is an where both patients and doctors know the treatment given 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.
View original scientific description
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.
Interventions
DEVICE
Non-invasive taVNS
Device activates the vagus through the ear. The device is controlled via the Vagustim mobile app, which connects using Bluetooth Low Energy (BLE).
Primary outcome measures
Number of adverse event and serious adverse events
Time frame: 12 months
Safety is assessed by adverse event.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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)
Where
- New York, New York
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Mar 13, 2026 · Source of record for eligibility and locations