Vagus nerve stimulation for autism and developmental disorders
Vagus Nerve Stimulation for Autonomic Dysregulation in Individuals With Developmental Disorders
NA · New York State Institute for Basic Research · NCT06259201
This study is testing if a safe treatment using vagus nerve stimulation can help improve behavior and daily life for children and adults with autism and other developmental disorders.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 12 Years to 40 Years |
| Sex | All |
| Sponsor | New York State Institute for Basic Research (other gov) |
| Locations | 2 sites (New York, New York and 1 other locations) |
| Trial ID | NCT06259201 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of non-invasive vagus nerve stimulation (VNS) on behavioral, cognitive, and biorhythmic symptoms in children and adults with autism spectrum disorder and other developmental disabilities. Participants can choose to undergo daily VNS treatment for 1, 2, or 3 months, with monthly study visits to monitor changes. The research aims to create a profile of individuals who may respond positively to VNS, ultimately guiding future clinical trials. The study utilizes FDA-approved VNS technology, which is known to influence autonomic nervous system functions.
Who should consider this trial
Good fit: Ideal candidates include children and adults aged 12-40 with intellectual and developmental disabilities and/or autism spectrum disorder.
Not a fit: Patients with active implantable medical devices or significant comorbid conditions that could interfere with VNS may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved management of symptoms associated with autism and developmental disabilities.
How similar studies have performed: While the use of vagus nerve stimulation has shown promise in other conditions, this specific application for autism and developmental disorders is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
New York, New York and 1 other locations
- New York State Psychiatric Institute — New York, New York, United States (NOT_YET_RECRUITING)
- New York State Institute for Basic Research — Staten Island, New York, United States (RECRUITING)
Study contacts
- Principal investigator: Helen Yoo, Ph.D. — New York State Institute for Basic Research
- Study coordinator: Helen Yoo, Ph.D.
- Email: jhelen.yoo@opwdd.ny.gov
- Phone: 718-494-5295
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Autism Spectrum Disorder, Intellectual Disability, Autonomic Nervous System, Developmental Disability, Vagus Nerve Stimulation