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NCT07394608 | RECRUITING | Cerebral Palsy

Paired Non-invasive VNS in Adolescent Cerebral Palsy Rehabilitation
Sponsor:

Icahn School of Medicine at Mount Sinai

Information provided by (Responsible Party):

David Putrino

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.

Condition or disease

Cerebral Palsy

Intervention/treatment

Non-invasive taVNS

Phase

NA

Study Type : INTERVENTIONAL
Estimated Enrollment : 10 participants
Masking : NONE
Primary Purpose : OTHER
Official Title : Use of Paired Non-Invasive Vagus Nerve Stimulation in Rehabilitation of Adolescents With Cerebral Palsy: An Open Label Safety Feasibility Trial
Actual Study Start Date : 2026-04
Estimated Primary Completion Date : 2028-03-01
Estimated Study Completion Date : 2028-03-01

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 12 Years to 17 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
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)
Paired Non-invasive VNS in Adolescent Cerebral Palsy Rehabilitation

Location Details

NCT07394608

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How to Participate

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Locations

RECRUITING

United States, New York

The Charles Lazarus Children's Abilities Center

New York, New York, United States, 10029