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Device

tVNS for Anxiety

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

Study 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.Check my eligibility

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.See study design

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of participants experiencing adverse outcomes as measured by questionnaire

Secondary outcome measures

Anxiety rating for participants using generalized anxiety disorder -child scale

Empagthic abilities as measured by the Toronto Empathy Questionnaire

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Medical University of South CarolinaLead Sponsor

933 Previous Clinical Trials

7,394,626 Total Patients Enrolled

7 Trials studying Anxiety

678 Patients Enrolled for Anxiety

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals currently able to apply and participate in this ongoing medical trial?

"Indeed, the details on clinicaltrials.gov reveal that this study is actively seeking participants. Originally shared on March 6th, 2024, and last revised on the same date, it aims to enroll 10 patients from a single site."

Answered by AI

Does this medical research study include individuals above the age of 35?

"Individuals aged between 12 and 17 years old meet the age requirements for participation in this clinical trial."

Answered by AI

What is the current number of participants being recruited for this clinical investigation?

"Indeed, the information on clinicaltrials.gov shows that this study is actively looking for eligible individuals. The trial was first listed on March 6th, 2024 and last revised on the same day. It aims to enroll 10 participants from a single site."

Answered by AI

What criteria must individuals meet in order to be eligible for participation in this clinical trial?

"This clinical study aims to recruit 10 adolescents aged between 12 and 17 years with existing anxiety disorders. Eligible participants must fulfill the subsequent conditions: proficient in English, within the age bracket of 12-17 years, previously diagnosed with Autism Spectrum Disorder using the autism diagnostic observation schedule (ADOS), SCARED score exceeding 24, IQ surpassing 70, capable of expressing their own agreement through assent while legal guardians provide consent."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

taVNS for Anxiety in ASD

Stewart Cox 2024. "taVNS for Anxiety in ASD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06258590.

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