Vagus Nerve Stimulator for Autism and Other Developmental Disorders

Description

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

Autism Spectrum Disorder, Intellectual Disability, Autonomic Nervous System, Developmental Disability

Study Overview

Study Details

Study overview

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.

Vagus Nerve Stimulation for Autonomic Dysregulation in Individuals With Developmental Disorders

Vagus Nerve Stimulator for Autism and Other Developmental Disorders

Condition
Autism Spectrum Disorder
Intervention / Treatment

-

Contacts and Locations

New York

New York State Psychiatric Institute, New York, New York, United States, 10032

Staten Island

New York State Institute for Basic Research, Staten Island, New York, United States, 10314

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

12 Years to 40 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

New York State Institute for Basic Research,

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

Study Record Dates

2026-12