Vagus Nerve Stimulator for Autism and Other Developmental Disorders

Launched by NEW YORK STATE INSTITUTE FOR BASIC RESEARCH · Feb 6, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the effects of a treatment called vagus nerve stimulation (VNS) on children and adults with autism spectrum disorder and other developmental disabilities. The goal is to understand how VNS can improve behavior, thinking skills, and daily rhythms in individuals affected by these conditions. Researchers want to identify who might benefit the most from this treatment, with hopes of designing larger studies in the future.

To participate in this study, individuals must be between the ages of 12 and 40 and have an intellectual or developmental disability or autism. They should be stable on their current medications and able to wear devices like an Apple Watch for monitoring. Participants can choose to undergo daily VNS treatment for one, two, or three months and will visit the study site each month for assessments. It’s important to note that certain health conditions and devices may prevent someone from being eligible, so a careful review will be conducted before enrollment. This trial is currently recruiting participants, and it offers a chance to explore a new potential treatment option.

Gender

ALL

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