Actively Recruiting
Paired Non-invasive VNS in Adolescent Cerebral Palsy Rehabilitation
Led by Icahn School of Medicine at Mount Sinai · Updated on 2026-03-13
10
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Paired Non-invasive VNS in Adolescent Cerebral Palsy Rehabilitation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 12-17 years old
- Diagnosis of spastic cerebral palsy
- Gross Motor Function Classification System (GMFCS) Level II-III
- Jebsen Taylor Hand Function Test Score of less than 37.08 on the affected side
- Ability to communicate and follow two-step commands
- Ability to provide assent based on assessment using the University of California, San Diego Brief Assessment of Capacity to Consent
You will not qualify if you...
- Previous vagus nerve injury
- Younger than 12 years old or older than 18 years old
- History of left or bilateral vagotomy
- Current use of implanted stimulation devices such as pacemakers, deep brain stimulators, implanted vagus nerve stimulators, cochlear implants, or implantable cardiac defibrillators
- Current use of any other investigational devices or drugs not otherwise specified
- History of 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 orthostatic hypotension, postural orthostatic tachycardia syndrome, vasovagal syncope
- GMFCS score less than II or greater than III
- Jebsen Taylor Hand Function Test Score greater than 37.08 on the affected side
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Charles Lazarus Children's Abilities Center
New York, New York, United States, 10029
Actively Recruiting
Research Team
J
Jenna Tosto Mancuso, PT, DPT,NCS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
OTHER
Number of Arms
1
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