Paired Non-invasive VNS in Adolescent Cerebral Palsy Rehabilitation

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT07394608
Status
Recruiting
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Conditions

  • Cerebral Palsy

Eligibility Criteria

Sex
ALL
Age
12 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Non-invasive taVNS — DEVICE
    Device activates the vagus through the ear. The device is controlled via the Vagustim mobile app, which connects using Bluetooth Low Energy (BLE).

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Feb 2026
Primary completion
Mar 1, 2028
Completion
Mar 1, 2028

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

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

Primary Outcome Measure

Number of adverse event and serious adverse events [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The Charles Lazarus Children's Abilities CenterNew YorkNew York10029
Jenna Tosto Mancuso, PT, DPT,NCS
[email protected]
212-241-8454
David Putrino (PRINCIPAL_INVESTIGATOR)

Find similar trials in New York, NY

By research site
The Charles Lazarus Children's Abilities Center· New York, NY

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