Paired Non-invasive VNS in Adolescent Cerebral Palsy Rehabilitation

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

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.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Palsy
• Intervention / Treatment: Device: Non-invasive taVNS

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jenna Tosto Mancuso, PT, DPT,NCS; Phone Number: 212-241-8454; Email: jenna.tosto@mountsinai.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • The Charles Lazarus Children's Abilities Center
      • Principal Investigator: David Putrino
      • Contact: Jenna Tosto Mancuso, PT, DPT,NCS; Phone Number: 212-241-8454; Email: jenna.tosto@mountsinai.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Non-invasive VNS; Non-invasive, transauricular, vagus nerve stimulation device will be used during physical therapy rehabilitation sessions	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).; Other Names: Vagustim; Non-invasive, transauricular, vagus nerve stimulation device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of adverse event and serious adverse events	Safety is assessed by adverse event.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of therapy sessions complete	Number of therapy sessions complete	end of therapy visits at Day 46
Active training time per session	Number of minutes of training per session	end of therapy visits at Day 46
Number of movement repetitions completed per session	Number of movement repetitions completed per session.	end of therapy visits at Day 46
Jebsen Taylor Hand Function Test (JTHFT)	The Jebsen Taylor Hand Function Test (JTHFT) is a standardized and objective measure of fine and gross motor hand functions that uses simulated activities of daily living (ADLs) assessed by time to completion; typically up to several minutes depending on impairment	baseline Day 1, start of therapy Day 3, end of therapy Day 46, and 3, 6, 9, and 12 months
BOT-2	The BOT-2 is a standardized assessment of motor proficiency in children and adolescents. It evaluates fine motor skills, manual dexterity, coordination, and motor integration through structured performance tasks. Fine Motor Precision (Upper Extremity) scored 0-41, higher score indicates better precision Fine Motor Integration (Upper Extremity) scored 0-45, higher score indicates better integration Manual Dexterity (Upper Extremity) scored 0- 45, higher score indicates better manual dexterity. Upper-Limb Coordination scored 0-30, higher score indicates better upper-limb coordination.	baseline Day 1, start of therapy Day 3, end of therapy Day 46, and 3, 6, 9, and 12 months
ABILHANDS	ABILHAND is a patient-reported outcome measure that evaluates a person's perceived manual ability to perform daily bimanual activities. It assesses how difficult activities are to perform using both hands. The ABILHAND-Kids logit score ranges from -6 logits to +6 logits, higher score indicates better bimanual manual ability (tasks are perceived as easier).	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)	The PEDI assesses functional abilities and performance in children across three domains: self-care, mobility, and social function. It measures both capability and caregiver assistance. Subscale range and full range uses scaled scores standardized to a 0-100 metric. Higher scores indicate better functional abilities and greater independence.	at 12 months
Pediatric Quality of Life Inventory (PedsQL)	The PedsQL is a standardized patient-reported outcome measure assessing health-related quality of life in children across domains including physical, emotional, social, and school functioning. Subscales range and full scale scores are transformed to a 0-100 scale. Higher scores indicate better health-related quality of life.	baseline Day 1, start of therapy Day 3, end of therapy Day 46, and 3, 6, 9, and 12 months

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: David Putrino, PhD, ICAHN School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: January 30, 2026
• First Submitted That Met QC Criteria: January 30, 2026
• First Posted (Actual): February 6, 2026

Study Record Updates

• Last Update Posted (Actual): March 13, 2026
• Last Update Submitted That Met QC Criteria: March 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Damage, Chronic; Cerebral Palsy
• Other Study ID Numbers: STUDY-25-01164

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No: There is not a plan to make IPD available.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes