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Device

Vagus Nerve Stimulation for Autism (VNS Trial)

N/A
Recruiting
Led By Helen Yoo, Ph.D.
Research Sponsored by New York State Institute for Basic Research
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Must not have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up every 4 weeks for 3, 4, or 5 months
Awards & highlights

Summary

"This trial aims to study the effects of vagus nerve stimulation (VNS) on behavior, cognition, and biorhythms in children and adults with autism and developmental disabilities. The main goals are

Who is the study for?
This trial is for children and adults with autism or developmental disabilities. Participants will choose to receive daily Vagus Nerve Stimulation (VNS) treatment for 1, 2, or 3 months and attend monthly study visits. Specific eligibility criteria are not provided.Check my eligibility
What is being tested?
The study tests the effects of VNS on behavior, cognition, and biological rhythms in participants with autism and developmental disorders. It aims to identify who might benefit from VNS and observe how it influences a range of symptoms.See study design
What are the potential side effects?
Potential side effects of VNS may include voice changes, coughing, throat pain or tingling, difficulty swallowing, shortness of breath during exercise, or skin irritation where the device is placed.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have issues with my vagus nerve, like damage, pain, or surgery history.
Select...
I have a history of neurological issues or head injury.
Select...
I cannot make medical decisions for myself and do not have a family member who can.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~every 4 weeks for 3, 4, or 5 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and every 4 weeks for 3, 4, or 5 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Aberrant Behavior Checklist-Community (ABC-C)
Behavior Rating Inventory of Executive Function (BRIEF)
Pervasive Developmental Disorder Behavior Inventory (PDDBI)
+3 more
Secondary outcome measures
Biorhythmic motion measurements
Electro-encephalogram (EEG)
Neurocognitive assessment
Other outcome measures
Clinical Global Impression Scale Severity & Improvement (CGI-S, CGI-I)
Columbia-Suicide Severity Rating Scale (C-SSRS)
Non-verbal Pain Measure

Trial Design

1Treatment groups
Experimental Treatment
Group I: Vagus Nerve Stimulation (VNS)Experimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Vagus Nerve Stimulation
2019
N/A
~50

Find a Location

Who is running the clinical trial?

New York State Institute for Basic ResearchLead Sponsor
6 Previous Clinical Trials
889 Total Patients Enrolled
Rutgers UniversityOTHER
114 Previous Clinical Trials
2,804,298 Total Patients Enrolled
Boston Children's HospitalOTHER
773 Previous Clinical Trials
5,580,876 Total Patients Enrolled
7 Trials studying Intellectual Disability
103,853 Patients Enrolled for Intellectual Disability
~50 spots leftby Dec 2026
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