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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

No Placebo-Only Group

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ every 4 weeks for 3, 4, or 5 months

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Aberrant Behavior Checklist-Community (ABC-C)

Behavior Rating Inventory of Executive Function (BRIEF)

Pervasive Developmental Disorder Behavior Inventory (PDDBI)

+3 more

Secondary study objectives

Biorhythmic motion measurements

Electro-encephalogram (EEG)

Neurocognitive assessment

Other study objectives

Clinical Global Impression Scale Severity & Improvement (CGI-S, CGI-I)

Columbia-Suicide Severity Rating Scale (C-SSRS)

Non-verbal Pain Measure

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 3Eligibility criteria met