Recruiting

VNS & UE Rehabilitation

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT07394608

Conditions

Cerebral Palsy

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Interventions

Non-invasive taVNS

Study Details

Brief summary:

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.

Conditions

Cerebral Palsy

Study ID

NCT07394608

Start date

Apr, 2026

Status verified date

Feb, 2026

Completion date

Mar 1, 2028

Anticipated

Primary completion date

Mar 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

10 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Non-invasive VNS

Non-invasive, transauricular, vagus nerve stimulation device will be used during physical therapy rehabilitation sessions

Interventions

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 measure

  • Number of adverse event and serious adverse events [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

Jenna Tosto Mancuso, PT, DPT,NCS

212-241-8454jenna.tosto@mountsinai.org

Locations

The Charles Lazarus Children's Abilities Center

Recruiting

New York, New York, United States, 10029

Contacts

Jenna Tosto Mancuso, PT, DPT,NCS

212-241-8454jenna.tosto@mountsinai.org

Principal Investigator:

David Putrino

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Mar 13, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-03-13.