Clinical trial NCT06259201: Vagus Nerve Stimulator for Autism and Other Developmental Disorders
Official title: Vagus Nerve Stimulation for Autonomic Dysregulation in Individuals With Developmental Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Autism Spectrum Disorder
Intellectual Disability
Autonomic Nervous System
Developmental Disability
Keywords: Vagus Nerve Stimulation
Lead sponsor: New York State Institute for Basic Research
Sponsor class: OTHER_GOV
Collaborators: name: Boston Children's Hospital
name: Rutgers University
First posted: 2024-02-14
Enrollment: 75
Sex: ALL
Minimum age (years): 12
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Aberrant Behavior Checklist-Community (ABC-C)
timeFrame: Change measured once per month for 3, 4, or 5 months
measure: Pervasive Developmental Disorder Behavior Inventory (PDDBI)
timeFrame: Change measured once per month for 3, 4, or 5 months
measure: Behavior Rating Inventory of Executive Function (BRIEF)
timeFrame: Change measured once per month for 3, 4, or 5 months
measure: The Symptom Checklist-90-Revised (SCL-90-R)
timeFrame: Change measured once per month for 3, 4, or 5 months
measure: Repetitive Behavior Scale-Revised (RBS-R)
timeFrame: Change measured once per month for 3, 4, or 5 months
measure: Yale-Brown Obsessive Compulsive Scale (Y-BOCS) (Y-BOCS)
timeFrame: Change measured once per month for 3, 4, or 5 months
Secondary outcomes:
measure: Neurocognitive assessment
timeFrame: Change measured once per month for 3, 4, or 5 months
measure: Electro-encephalogram (EEG)
timeFrame: Change measured once per month for 3, 4, or 5 months
measure: Biorhythmic motion measurements
timeFrame: Change measured once per month for 3, 4, or 5 months
Other outcomes:
measure: Non-verbal Pain Measure
timeFrame: Twice per day for 3, 4, or 5 months
measure: Columbia-Suicide Severity Rating Scale (C-SSRS)
timeFrame: every 4 weeks for 3, 4, or 5 months
measure: Clinical Global Impression Scale Severity & Improvement (CGI-S, CGI-I)
timeFrame: Change measured once per month for 3, 4, or 5 months
Locations:
city: New York
country: United States
facility: New York State Psychiatric Institute
state: New York
city: Staten Island
country: United States
facility: New York State Institute for Basic Research
state: New York
Study officials:
affiliation: New York State Institute for Basic Research
name: Helen Yoo, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: