Vagus Nerve Stimulator for Autism and Other Developmental Disorders

Withdrawn before enrolling · Not applicable

Conditions studied: Autism Spectrum Disorder, Intellectual Disability, Autonomic Nervous System, Developmental Disability

In brief

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.

Key facts

Study ID

NCT06259201

Run by

New York State Institute for Basic Research

People needed

0

Starts

2025-05-01

Expected to finish

2027-12-01

Last updated by the study team

2026-02-13

Who can join

Age: 12 and older, up to 40. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children and adults aged 12-40 with intellectual and developmental disability (IDD) and/or autism spectrum disorder (ASD). Participants who are decisionally-impaired will be eligible with assent.
• Able to tolerate wearing an Apple Watch, EEG, and sit for a neurocognitive test
• Be on a stable dose of psychotropic medication for at least one month prior to enrollment
• Agree not to initiate new or change existing medications or behavior intervention

You may not qualify if…

• Have an active implantable medical device (e.g., pacemaker, implanted hearing aid, etc.) or a metallic device, such as a stent, bone plate, or bone screw
• Have a comorbid physical or psychiatric disorder which would disrupt ability to tolerate vagal stimulation or comply with study demands (e.g., insulin dependent diabetes, bipolar, etc.)
• Vagus nerve lesion, damage, or structural abnormality (e.g., lymphadenopathy, neoplasm, previous surgery), or pain (e.g., dysesthesia, neuralgia and/or cervicalgia)
• Current or past history of neurological disorders or trauma, including uncontrolled epilepsy and head injury.
• Current or recent (within 12 months) participation in a clinical trial of a drug or a medical device.
• Use of drugs (within 4 weeks) that affect the autonomic nervous system (beta blockers, beta stimulant, etc.).
• Use of marijuana (including medical marijuana) for any indication
• Any condition per the investigators' clinical judgment that precludes participation in the study (e.g., pregnancy).
• Lack of capacity to consent and without a legally authorized representative (LAR) who is a parent, spouse, or an adult child.
• Living in a residential program (e.g., group home)
• Wards of state

Where it is running

• New York State Psychiatric Institute — New York, New York, United States
• New York State Institute for Basic Research — Staten Island, New York, United States

Full record on ClinicalTrials.gov

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