Autism Spectrum Disorder Clinical Trial
— VNSOfficial 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.
Status | Recruiting |
Enrollment | 75 |
Est. completion date | December 2026 |
Est. primary completion date | December 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 12 Years to 40 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | New York State Psychiatric Institute | New York | New York |
United States | New York State Institute for Basic Research | Staten Island | New York |
Lead Sponsor | Collaborator |
---|---|
New York State Institute for Basic Research | Boston Children's Hospital, Rutgers University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Non-verbal Pain Measure | Non-verbal Pain and Discomfort Indicators for those participants who are non-verbal. Minimum score = 0; maximum score = 8. Higher scores indicate more pain and discomfort. | Twice per day for 3, 4, or 5 months | |
Other | Columbia-Suicide Severity Rating Scale (C-SSRS) | C-SSRS is a suicidal ideation and behavior rating scale to evaluate suicide risk. It rates one's degree of suicidal ideation on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent and behaviors." An answer of "yes" to any of the six questions may indicate a need for referral and an answer of "yes" to questions 4, 5 or 6 indicate high-risk. | every 4 weeks for 3, 4, or 5 months | |
Other | Clinical Global Impression Scale Severity & Improvement (CGI-S, CGI-I) | measures of symptom severity, treatment response and the efficacy of treatments. Minimum score = 1; maximum score = 7. Higher scores indicate more severity (CGI-S) or worsening (CGI-I). | Change measured once per month for 3, 4, or 5 months | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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. | Change measured once per month for 3, 4, or 5 months | |
Secondary | 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. |
Change measured once per month for 3, 4, or 5 months | |
Secondary | 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. |
Change measured once per month for 3, 4, or 5 months |
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