NCT07394608

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
22mo left

Started Apr 2026

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Apr 2026Mar 2028

First Submitted

Initial submission to the registry

January 30, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 6, 2026

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2028

Last Updated

March 13, 2026

Status Verified

February 1, 2026

Enrollment Period

1.9 years

First QC Date

January 30, 2026

Last Update Submit

March 11, 2026

Conditions

Cerebral Palsy

Outcome Measures

Primary Outcomes (1)

  • Number of adverse event and serious adverse events

    Safety is assessed by adverse event.

    12 months

Secondary Outcomes (8)

  • Number of therapy sessions complete

    end of therapy visits at Day 46

  • Active training time per session

    end of therapy visits at Day 46

  • Number of movement repetitions completed per session

    end of therapy visits at Day 46

  • Jebsen Taylor Hand Function Test (JTHFT)

    baseline Day 1, start of therapy Day 3, end of therapy Day 46, and 3, 6, 9, and 12 months

  • BOT-2

    baseline Day 1, start of therapy Day 3, end of therapy Day 46, and 3, 6, 9, and 12 months

  • +3 more secondary outcomes

Study Arms (1)

Non-invasive VNS

EXPERIMENTAL

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

Device: Non-invasive taVNS

Interventions

Non-invasive taVNSDEVICE

Device activates the vagus through the ear. The device is controlled via the Vagustim mobile app, which connects using Bluetooth Low Energy (BLE).

Also known as: Non-invasive, transauricular, vagus nerve stimulation device, Vagustim
Non-invasive VNS

Eligibility Criteria

Age12 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Charles Lazarus Children's Abilities Center

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • David Putrino, PhD

    Icahn School of Medicine at Mount Sinai

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jenna Tosto Mancuso, PT, DPT,NCS

CONTACT

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Open-label
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 30, 2026

First Posted

February 6, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

March 1, 2028

Study Completion (Estimated)

March 1, 2028

Last Updated

March 13, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

No: There is not a plan to make IPD available.

Locations

US(1)