Vagus Nerve Stimulation for Anxiety in Autism

N/A

Recruiting

Research Sponsored by Medical University of South Carolina

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 weeks during trial with 30 day follow-up to assess adverse effects

Awards & highlights

No Placebo-Only Group

Summary

This trial will recruit 10 patients with Anxiety and Autism Spectrum Disorder. The study will test the safety and practicality of using transcutaneous auricular vagus nerve stimulation (taVNS) as

Who is the study for?

This trial is for English-speaking individuals aged 12-17 with Autism Spectrum Disorder (ASD) who also experience anxiety. They must have been previously diagnosed using the ADOS, score above 24 on the SCARED anxiety scale, and have an IQ over 70. Participants need to be able to give their own assent while consent will be provided by a legal guardian.

What is being tested?

The study tests transcutaneous auricular vagus nerve stimulation (taVNS), a non-drug wearable intervention for managing anxiety in ASD patients at home. It involves self-administering taVNS twice daily for four weeks without affecting other mental health treatments.

What are the potential side effects?

Previous studies suggest that taVNS is generally safe and well-tolerated when used at home under remote monitoring. Specific side effects are not listed but may include discomfort or irritation where the device attaches.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 weeks during trial with 30 day follow-up to assess adverse effects

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 weeks during trial with 30 day follow-up to assess adverse effects

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 weeks during trial with 30 day follow-up to assess adverse effects for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Number of participants experiencing adverse outcomes as measured by questionnaire

Secondary study objectives

Anxiety rating for participants using generalized anxiety disorder -child scale

Empagthic abilities as measured by the Toronto Empathy Questionnaire

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: tVNSExperimental Treatment1 Intervention

All patients will receive at-home Transcutaneous auricular vagus nerve stimulation (taVNS) and assess the impact on multiple behavioral outcomes associated with ASD and anxiety. This is an open-label trial.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transcutaneous auricular vagus nerve stimulation

2023

N/A

~40

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