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Vagus nerve study for autism withdrawn before starting

NCT ID NCT06259201

Knowledge-focused Sponsor: New York State Institute for Basic Research Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study planned to test vagus nerve stimulation (VNS) in children and adults with autism and developmental disabilities to see if it could improve behavior, thinking, and body rhythms. Participants would have chosen 1 to 3 months of daily VNS and completed monthly check-ins. The study was withdrawn before enrolling anyone, so no results are available.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Expected to start

May 2025

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 40 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. 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. 2. Able to tolerate wearing an Apple Watch, EEG, and sit for a neurocognitive test 3. Be on a stable dose of psychotropic medication for at least one month prior to enrollment 4. Agree not to initiate new or change existing medications or behavior intervention Exclusion Criteria: 1. 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 2. 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.) 3. Vagus nerve lesion, damage, or structural abnormality (e.g., lymphadenopathy, neoplasm, previous surgery), or pain (e.g., dysesthesia, neuralgia and/or cervicalgia) 4. Current or past history of neurological disorders or trauma, including uncontrolled epilepsy and head injury. 5. Current or recent (within 12 months) participation in a clinical trial of a drug or a medical device. 6. Use of drugs (within 4 weeks) that affect the autonomic nervous system (beta blockers, beta stimulant, etc.). 7. Use of marijuana (including medical marijuana) for any indication 8. Any condition per the investigators' clinical judgment that precludes participation in the study (e.g., pregnancy). 9. Lack of capacity to consent and without a legally authorized representative (LAR) who is a parent, spouse, or an adult child. 10. Living in a residential program (e.g., group home) 11. Wards of state

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Conditions

The condition(s) this trial relates to.

autism spectrum disorder autonomic nervous system disorder developmental disability intellectual disability

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Autism spectrum disorder Autonomic nervous system Developmental disability Intellectual disability

Contacts and locations

Locations

  • New York State Institute for Basic Research

    Staten Island, New York, 10314, United States

  • New York State Psychiatric Institute

    New York, New York, 10032, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.