Vagus Nerve Stimulator for Autism and Other Developmental Disorders

NCT06259201 | Withdrawn FDA Device

• 1 other identifier: NYInstitute
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 2

Brief Summary

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

Keywords

Vagus Nerve Stimulation

Outcome Measures

Primary Outcomes (6)

• Aberrant Behavior Checklist-Community (ABC-C)

  The ABC-C is a 58-item questionnaire consisting of five subscales: Irritability, Lethargy, Inappropriate Speech, Hyperactivity, and Stereotypy. Minimum score = 0, maximum score = 174. Higher scores indicate more severity.

  Change measured once per month for 3, 4, or 5 months

• Pervasive Developmental Disorder Behavior Inventory (PDDBI)

  The PDDBI is an informant-based assessment that examines treatment effectiveness and differentiates ASD from other conditions. It consists of the following Approach/Withdrawal Problems: 1) Sensory/Perceptual Approach, 2) Ritualisms/Resistance to Change, 3) Social Pragmatic, 4) Semantic Pragmatic, 5) Arousal Regulation, 6) Specific Fears, 7) Aggressiveness. Under Receptive/ Expressive Social Communication Abilities, there are 1) Social Approach Behaviors, 2) Expressive Language, and 3) Learning, Memory, and Receptive Language. Higher T scores on Approach/Withdrawal Problems indicate more symptom severity and higher T scores on Receptive/Expressive Social Communication indicate more skills.

  Change measured once per month for 3, 4, or 5 months

• Behavior Rating Inventory of Executive Function (BRIEF)

  The BRIEF is an informant-based assessment that contains 63 (preschool age) 86 (school age) items with eight subdomains of executive function: 1) Inhibit, 2) Shift, and 3) Emotional Control subdomains together result in an additional composite Behavioral Regulation Index. The subdomains 4) Initiate, 5) Working Memory, 6) Plan/Organize, 7) Organization of Materials, and 8) Monitor provide a composite Metacognition Index. The indexes are also combined to obtain an overall Global Executive Composite. Higher T scores indicate more symptom severity.

  Change measured once per month for 3, 4, or 5 months

• The Symptom Checklist-90-Revised (SCL-90-R)

  The SCL-90-R is a questionnaire designed to evaluate a broad range of psychological problems and symptoms of psychopathology. It is also useful in measuring treatment outcomes. Higher T scores indicate more symptom severity.

  Change measured once per month for 3, 4, or 5 months

• Repetitive Behavior Scale-Revised (RBS-R)

  The RBS-R is a 44-item questionnaire that is used to measure the breadth of repetitive behavior in people with ASD. The RBS-R consists of six subscales including: Stereotyped, Self-injurious, Compulsive, Routine, Sameness, and Restricted Behaviors. Minimum score = 0; maximum score = 136. Higher scores indicate more severity.

  Change measured once per month for 3, 4, or 5 months

• Yale-Brown Obsessive Compulsive Scale (Y-BOCS) (Y-BOCS)

  The Y-BOCS is a measurement tool for OCD. It is not a diagnostic tool. Rather, it is a scale used to gauge the severity and nature of OCD symptoms and to monitor improvement. Higher scores indicate severity. Minimum score = 0; maximum score = 40. Higher scores indicate more severity.

  Change measured once per month for 3, 4, or 5 months

Secondary Outcomes (3)

• Neurocognitive assessment

  Change measured once per month for 3, 4, or 5 months

• Electro-encephalogram (EEG)

  Change measured once per month for 3, 4, or 5 months

• Biorhythmic motion measurements

  Change measured once per month for 3, 4, or 5 months

Other Outcomes (3)

• Non-verbal Pain Measure

  Twice per day for 3, 4, or 5 months

• Columbia-Suicide Severity Rating Scale (C-SSRS)

  every 4 weeks for 3, 4, or 5 months

• Clinical Global Impression Scale Severity & Improvement (CGI-S, CGI-I)

  Change measured once per month for 3, 4, or 5 months

Study Arms (1)

Vagus Nerve Stimulation (VNS)

EXPERIMENTAL

Single-subject design: ABA, ABBA, or ABBBA This study allows for a flexibility in the duration of research participation depending on one's response. The participant will be able to select one of the three design options (1, 2, or 3 months of VNS twice per day) in consultation with the study staff. That is, after the initial 1-month trial of VNS, the participant may choose to extend the VNS two more times (i.e., 1 or 2 months), for a total of 90 days.

Device: Vagus Nerve Stimulation

Interventions

Vagus Nerve Stimulation DEVICE

Vagal nerve stimulation (VNS) involves the use of a device to stimulate the vagus nerve with electrical impulses twice per day (AM \& PM) for two minutes each. It is an approved treatment for treatment resistant epilepsy and depression.

Also known as: gammaCore

Vagus Nerve Stimulation (VNS)

Eligibility Criteria

• Age: 12 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

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

Sponsors & Collaborators

• New York State Institute for Basic Research: lead

Study Sites (2)

New York State Psychiatric Institute

New York, New York, 10032, United States

Location

New York State Institute for Basic Research

Staten Island, New York, 10314, United States

Location

MeSH Terms

Conditions

Autism Spectrum Disorder; Intellectual Disability; Developmental Disabilities

Interventions

Vagus Nerve Stimulation

Condition Hierarchy (Ancestors)

Child Development Disorders, Pervasive; Neurodevelopmental Disorders; Mental Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics

Study Officials

• Helen Yoo, Ph.D.

  New York State Institute for Basic Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Each participant will begin the study with the first baseline phase (1 month). Each participant will receive 1 month of VNS administered twice per day (AM \& PM). During the study, the participant (or legal guardian) and the study team can decide whether to: 1. Complete 1 month of VNS and go to Baseline 2 (ABA design); or 2. Continue with 2 months of VNS and go to Baseline 2 (ABBA design); or 3. Continue with 3 months of VNS and go to Baseline 2 (ABBBA design) Each participant will have 1-month, 3-month, and 6-month follow-ups with the study team.

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: February 14, 2024
• Study Start: May 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: February 13, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)