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Vagus Nerve Stimulator for Autism and Other Developmental Disorders

NCT06259201 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2026-02-13

No results posted yet for this study

Summary

The goal of this flexible single-subject design vagus nerve stimulation (VNS) study is to examine the behavioral, cognitive, and biorhythmic effects of VNS in children and adults with autism and developmental disabilities. The main aims are:

* Pilot the creation of a profile for those who will respond to VNS with the long-term goal of designing clinical trials.
* Examine the effects of VNS on a broad range of symptoms.

Participants will select between 1, 2, or 3 months of daily VNS treatment and complete study visits each month.

Conditions

Interventions

DEVICE

Vagus Nerve Stimulation

Vagal nerve stimulation (VNS) involves the use of a device to stimulate the vagus nerve with electrical impulses twice per day (AM \& PM) for two minutes each. It is an approved treatment for treatment resistant epilepsy and depression.

Sponsors & Collaborators

  • New York State Institute for Basic Research

    lead OTHER_GOV

Principal Investigators

  • Helen Yoo, Ph.D. · New York State Institute for Basic Research

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-31
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06259201 on ClinicalTrials.gov