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Recruiting NCT07394608

Paired Non-invasive VNS in Adolescent Cerebral Palsy Rehabilitation

No phase Interventional Cerebral Palsy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non-invasive taVNS.
Who it may be relevant to
Registry conditions: Cerebral Palsy. Basic parameters: 12 years — 17 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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]
Secondary outcome measures (8)
  • Number of therapy sessions complete [Time frame: end of therapy visits at Day 46]
  • Active training time per session [Time frame: end of therapy visits at Day 46]
  • Number of movement repetitions completed per session [Time frame: end of therapy visits at Day 46]
  • Jebsen Taylor Hand Function Test (JTHFT) [Time frame: baseline Day 1, start of therapy Day 3, end of therapy Day 46, and 3, 6, 9, and 12 months]
  • BOT-2 [Time frame: baseline Day 1, start of therapy Day 3, end of therapy Day 46, and 3, 6, 9, and 12 months]
  • ABILHANDS [Time frame: baseline Day 1, start of therapy Day 3, end of therapy Day 46, and 3, 6, 9, and 12 months]
  • Pediatric Evaluation of Disability (PEDI) [Time frame: at 12 months]
  • Pediatric Quality of Life Inventory (PedsQL) [Time frame: baseline Day 1, start of therapy Day 3, end of therapy Day 46, and 3, 6, 9, and 12 months]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • The Charles Lazarus Children's Abilities Center — New York

Identifiers

NCT: NCT07394608 · STUDY-25-01164

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗