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Shocking anxiety away? Ear-Zap device tested for autism

NCT ID NCT06258590

Symptom relief Sponsor: Medical University of South Carolina Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This pilot study tested a wearable device that gently stimulates a nerve in the ear to help manage anxiety in teenagers with autism. Ten participants used the device at home twice daily for four weeks. The goal was to see if it was safe and easy to use, not yet to prove it works. Results may guide larger studies.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
transcutaneous auricular vagus nerve stimulation (taVNS) device
What this could lead to
If it works, this could point toward a non-drug, at-home option to ease anxiety for people with autism.
What could go wrong
This was a very small pilot study with only 10 participants and no placebo group. The results may not apply to everyone, and the device might not work for all.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

10 people

The number who actually took part.

Started

Apr 2024

Finished

Mar 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Ages 12-17 * English speaking * Prior diagnosis of ASD using autism diagnostic observation schedule (ADOS) * Score \>24 on SCARED * IQ \>70 * Have the capacity and ability to provide one's own assent, consent will be provided by legal guardian Exclusion Criteria: * Facial or ear pain or recent ear trauma. * Metal implant devices in the head, heart or neck. * History of brain surgery. * History of myocardial infarction or arrhythmia, bradycardia. * Acute exacerbation of a chronic respiratory disorder or acute COVID-related symptoms. * Active GI symptoms with a history of diabetes mellitus or history of gastroparesis secondary to diabetes mellitus. * Personal or family history of seizure or epilepsy or personal use of medications that substantially reduce seizure threshold (e.g., olanzapine, chlorpromazine, lithium). * Personal history of head injury, concussion, or self-report of moderate to severe traumatic brain injury. * Individuals suffering from frequent/severe headaches. * Individuals with a reported history of psychosis or mania, or individuals who are actively manic or psychotic. * Individuals who are catatonic or otherwise unable to participate in the informed consent process. * Moderate to severe alcohol or substance use disorder. * Pregnancy

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Conditions

The condition(s) this trial relates to.

anxiety anxiety disorder autism spectrum disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anxiety Autism spectrum disorder

Contacts and locations

Locations

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.