Autism Spectrum DisorderVNSNCT06259201
Vagus Nerve Stimulator for Autism and Other Developmental Disorders
A study testing Vagus Nerve Stimulation in people with Autism Spectrum Disorder and Intellectual Disability, run by New York State Institute for Basic Research at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 40 years
- Conditions the study is for
- Autism Spectrum Disorder, Intellectual Disability, Autonomic Nervous System
- What is being tested?
- Vagus Nerve Stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 2 sitesUnited States
- Study dates
- May 2025to Dec 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.).
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
New York State Psychiatric Institute
New York, New York, 10032
New York State Institute for Basic Research
Staten Island, New York, 10314
About this study
Official title: Vagus Nerve Stimulation for Autonomic Dysregulation in Individuals With Developmental Disorders
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.
Read the detailed description
Intellectual and developmental disabilities (IDD) cover a wide variety of disorders. Although we know the causes of some of the disorders and some of them could even be prevented (e.g., lead exposure), most causes remain unknown. Without having a clear understanding of the causes, prevention is very difficult to achieve. Previous studies have shown abnormal autonomic nervous system (ANS) regulations in young children with autism spectrum disorder (ASD) and these abnormalities are also observed during sleep. ANS is the part of the nervous system that controls the unconscious bodily functions, such as breathing, heart beating, and digestion.
The vagus nerve strongly influences these autonomic functions including digestion, breathing, heart rate variability, and metabolic function and central nervous system (CNS) activity that affect mood, pain, stress management, sleep, and even memory and cognitive functions. The vagal influence over neurotransmitter release has been implicated in the regulation of inflammation and immune cell activity.
Here, we are using a non-invasive vagus nerve stimulator to monitor changes in cognitive function and other symptoms in people with IDD, both with and without ASD. The device is FDA-approved for migraine and cluster headaches in people 12 years and older. VNS activates the vagus nerve with mild electrical stimulation through the skin.
Rather than embarking on a rigorously designed study, we will conduct a series of single-subject studies that reflects each participant's symptoms. We will select the most appropriate dependent variables based on each person's symptom presentation.
- Conditions
- Autism Spectrum Disorder, Intellectual Disability, Autonomic Nervous System, Developmental Disability
- Being tested
- Vagus Nerve Stimulation
- Keywords
- Vagus Nerve Stimulation
- Medical subject headings
- Autism Spectrum Disorder, Intellectual Disability, Developmental Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vagus Nerve StimulationDevice
Also called gammaCore
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Vagus Nerve Stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change measured once per month for 3, 4, or 5 months
Secondary outcomes (3)
Neurocognitive assessment
An online tablet-based nonverbal (i.e., visually presented on an iPad) neurocognitive tasks to examine specific components of cognition, particularly those associated with executive function skills related to frontal and medial temporal regions of the brain (e.g., planning, episodic memory, processing speed) will be collected. Subtests are specifically selected for IDD/ASD and graded in difficulty, minimizing floor and ceiling effects.
Measured: Change measured once per month for 3, 4, or 5 months
Electro-encephalogram (EEG)
EEG is a non-invasive test that records electrical activity in the brain. It works by picking up brain waves via electrodes that are attached to the scalp. EEG data will be collected for 10-15 mins while the participant is awake.
Power, sample entropy, Lyapunov exponent, detrended fluctuation analysis, correlation dimension, and recurrence quantitative analysis (RQA) values on all frequency bands (delta, theta, alpha, beta, gamma, and gamma+) will be computed using a portable headset.
Measured: Change measured once per month for 3, 4, or 5 months
Biorhythmic motion measurements
On-body sensors: Patterns of motor and heart variability in the form of time series collected to align the signals for before, during, and after VNS comparison.
OFF-body sensors: Time series of digital data to extract patterns of variability and stochastic signatures aligned to the stimulation.
Measured: Change measured once per month for 3, 4, or 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2024
- Study startMay 2025 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Why it stopped: Investigator decided to terminate the study - no participant enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autism Spectrum DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Institute for Basic Research
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Helen Yoo, Ph.D., Principal investigator, New York State Institute for Basic Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06259201
- Sponsor's protocol ID
- NYInstitute
- Acronym
- VNS
- Status last verified
- May 2025
- First submitted
- 7 Jul 2023
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Study withdrawn.
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vagus Nerve Stimulation for Autonomic Dysregulation in Individuals With Developmental Disorders
- ClinicalTrials.gov ID
- NCT06259201
- Acronym / sponsor ID
- VNS / NYInstitute
- Conditions
- Autism Spectrum Disorder, Intellectual Disability, Autonomic Nervous System, Developmental Disability
- Keywords
- Vagus Nerve Stimulation
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigator decided to terminate the study - no participant enrolled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- New York State Institute for Basic ResearchOther government
- Study start
- May 2025 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 14 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Intellectual and developmental disabilities (IDD) cover a wide variety of disorders. Although we know the causes of some of the disorders and some of them could even be prevented (e.g., lead exposure), most causes remain unknown. Without having a clear understanding of the causes, prevention is very difficult to achieve. Previous studies have shown abnormal autonomic nervous system (ANS) regulations in young children with autism spectrum disorder (ASD) and these abnormalities are also observed during sleep. ANS is the part of the nervous system that controls the unconscious bodily functions, such as breathing, heart beating, and digestion.
The vagus nerve strongly influences these autonomic functions including digestion, breathing, heart rate variability, and metabolic function and central nervous system (CNS) activity that affect mood, pain, stress management, sleep, and even memory and cognitive functions. The vagal influence over neurotransmitter release has been implicated in the regulation of inflammation and immune cell activity.
Here, we are using a non-invasive vagus nerve stimulator to monitor changes in cognitive function and other symptoms in people with IDD, both with and without ASD. The device is FDA-approved for migraine and cluster headaches in people 12 years and older. VNS activates the vagus nerve with mild electrical stimulation through the skin.
Rather than embarking on a rigorously designed study, we will conduct a series of single-subject studies that reflects each participant's symptoms. We will select the most appropriate dependent variables based on each person's symptom presentation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Vagus Nerve Stimulation (VNS) | Experimental | Device: Vagus Nerve StimulationSingle-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. |
Who may qualify
- Ages
- 12 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vagus Nerve StimulationAlso: gammaCoreVagal 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. | Device | Vagus Nerve Stimulation (VNS) |
Primary outcome
Aberrant Behavior Checklist-Community (ABC-C)
Time frame: Change measured once per month for 3, 4, or 5 months
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.
Pervasive Developmental Disorder Behavior Inventory (PDDBI)
Time frame: Change measured once per month for 3, 4, or 5 months
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.
Behavior Rating Inventory of Executive Function (BRIEF)
Time frame: Change measured once per month for 3, 4, or 5 months
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.
The Symptom Checklist-90-Revised (SCL-90-R)
Time frame: Change measured once per month for 3, 4, or 5 months
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.
Repetitive Behavior Scale-Revised (RBS-R)
Time frame: Change measured once per month for 3, 4, or 5 months
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.
Yale-Brown Obsessive Compulsive Scale (Y-BOCS) (Y-BOCS)
Time frame: Change measured once per month for 3, 4, or 5 months
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.
3 secondary outcomes
Neurocognitive assessment
Time frame: Change measured once per month for 3, 4, or 5 months
Electro-encephalogram (EEG)
Time frame: Change measured once per month for 3, 4, or 5 months
Biorhythmic motion measurements
Time frame: Change measured once per month for 3, 4, or 5 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Individual participant dataSharing planned: No. Study withdrawn.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helen Yoo, Ph.D. principal investigator
New York State Institute for Basic Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vagus Nerve Stimulation in people with Autism Spectrum Disorder and Intellectual Disability, run by New York State Institute for Basic Research at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aberrant Behavior Checklist-Community (ABC-C) (time frame: Change measured once per month for 3, 4, or 5 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.