NCT06259201Withdrawn
Vagus Nerve Stimulator for Autism and Other Developmental Disorders
Vagus Nerve Stimulation for Autonomic Dysregulation in Individuals With Developmental Disorders
Source: ClinicalTrials.gov · Last updated 13 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Withdrawn
- Study type
- Interventional
- Enrollment
- 0 (actual)
- First submitted
- 7 Jul 2023
- Start date
- May 2025
- Primary completion date
- Dec 2027
- Lead sponsor
- New York State Institute for Basic Research
- Diseases
- Autism
- NCT number
- NCT06259201
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Vagus nerve lesion, damage, or structural abnormality (e.g., lymphadenopathy, neoplasm, previous surgery), or pain (e.g., dysesthesia, neuralgia and/or cervicalgia)
- 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.).
Other illness
- 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.)
- Current or past history of neurological disorders or trauma, including uncontrolled epilepsy and head injury.
- Any condition per the investigators' clinical judgment that precludes participation in the study (e.g., pregnancy).
Other
- 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
- Use of marijuana (including medical marijuana) for any indication
- 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
Who the study is looking for
- 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
Age in the registry: 12 years to 40 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| New York State Psychiatric Institute | New York | United States | Unknown status |
| New York State Institute for Basic Research | Staten Island | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.