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Could a gentle brain zapper ease anxiety and help you sleep?

NCT ID NCT07429578

Symptom relief Sponsor: University of Sao Paulo Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 is testing a device that sends a mild electrical current to the brain (tACS) to see if it can reduce anxiety and improve sleep in people with generalized anxiety disorder and chronic insomnia. Thirty adults will receive 20 sessions over four weeks. The goal is to gather early evidence for a larger, more rigorous trial.

What this could mean

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

Active substance
transcranial alternating current stimulation (tACS) device
What this could lead to
If it works, this could point toward a non-drug treatment for anxiety and insomnia.
What could go wrong
This is a small, early pilot study with no placebo group, so results may not be reliable. The device is experimental and not yet proven.

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

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Jul 2026

An estimate. End dates often move.

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

18 to 65 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: Age between 18 and 65 years; Diagnosis of Generalized Anxiety Disorder (GAD) based on Diagnostic and Statistical Manual of Mental Disorders (DSM) criteria; Diagnosis of chronic primary insomnia; Hamilton Anxiety Rating Scale (HAM-A) score ≥15 at screening, indicating at least moderate anxiety severity; Score \>5 on the Pittsburgh Sleep Quality Index (PSQI); Stable use of antidepressants (SSRI or SNRI) is allowed; Limited use of benzodiazepines (maximum of 10 mg/day diazepam equivalent). Exclusion Criteria: History of mania, hypomania, or bipolar disorder; Contraindications to the use of transcranial stimulation; Active suicidal ideation or suicide attempt in the last 4 weeks; Refractoriness to 3 or more antidepressant treatments; Pregnancy; Other psychiatric diagnoses (e.g., schizophrenia, substance dependence, major depressive disorder); Severe medical or neurological conditions; Anxiety or insomnia secondary to other medical or psychiatric conditions (e.g., hypothyroidism, anemia).

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Conditions

The condition(s) this trial relates to.

generalized anxiety disorder insomnia sleep-wake disorder

As listed by the trial registrant

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

Chronic insomnia Generalized anxiety disorder (GAD)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of São Paulo

    RECRUITING

    São Paulo, São Paulo, 05403-010, Brazil

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