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

Use of Paired Non-Invasive Vagus Nerve Stimulation in Rehabilitation of Adolescents With Cerebral Palsy: An Open Label Safety Feasibility Trial

This trial tests non-invasive vagus nerve stimulation paired with upper-extremity rehabilitation to see if it safely improves arm and hand function in adolescents (12–17) with spastic cerebral palsy.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 12 Years to 17 Years
• Sex: All
• Sponsor: Icahn School of Medicine at Mount Sinai (other)
• Locations: 1 site (New York, New York)
• Trial ID: NCT07394608 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adolescents aged 12–17 with spastic cerebral palsy, GMFCS level II–III, measurable hand impairment (Jebsen Taylor Hand Function Test score under 37.08), who can follow two-step commands and give assent.

Not a fit: Patients outside the 12–17 age range, those without spastic cerebral palsy or with GMFCS levels outside II–III, individuals with prior vagus nerve injury or implanted electrical devices, or those unable to follow commands or provide assent are unlikely to benefit from or be eligible for this protocol.

Why it matters

Potential benefit: If successful, this approach could increase gains from arm and hand rehabilitation and improve functional use of the affected limb in adolescents with spastic cerebral palsy.

How similar studies have performed: Small studies pairing invasive or non-invasive VNS with rehabilitation in adults (for example after stroke) have shown promising motor gains, but paired taVNS in adolescent cerebral palsy remains relatively novel and not yet widely tested.

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)

Where this trial is running

New York, New York

• 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

Conditions: Cerebral Palsy