Non-invasive vagus nerve stimulation paired with arm rehab for teens with spastic cerebral palsy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This open-label safety and feasibility study delivers non-invasive transauricular vagus nerve stimulation (taVNS) paired with upper-extremity therapy to adolescent participants with spastic cerebral palsy. Participants are screened for age (12–17), GMFCS level II–III, and a Jebsen Taylor Hand Function Test score under 37.08 on the affected side, and must be able to follow two-step commands and provide assent. The protocol combines taVNS sessions with task-specific motor training and monitors safety, tolerability, and preliminary changes in motor impairment. The single-site study is conducted at the Charles Lazarus Children's Abilities Center at Mount Sinai in New York City and is not blinded or randomized.

Why it matters

Who can join: the full rules

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 it's running

• The Charles Lazarus Children's Abilities Center
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: David Putrino, PhD — Icahn School of Medicine at Mount Sinai
• Study coordinator: Jenna Tosto Mancuso, PT, DPT,NCS
• Email: jenna.tosto@mountsinai.org
• Phone: 212-241-8454

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.