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Brain zapping without surgery: new device targets deep brain regions to treat depression and anxiety

NCT ID NCT07712159

Symptom relief Sponsor: Central South University 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 17, 2026 · Last updated Jul 17, 2026

Summary

This clinical trial is testing a non-invasive brain stimulation method called temporal interference transcranial alternating current stimulation (TI-tACS) for people with major depressive disorder or generalized anxiety disorder. The device uses two high-frequency electrical currents to create a low-frequency field deep in the brain, targeting the right amygdala. Participants receive 20 sessions over two weeks and are followed for up to six months to see if symptoms improve compared to a sham (inactive) treatment.

What this could mean

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

Active substance
Temporal Interference transcranial Alternating Current Stimulation (TI-tACS), a non-invasive brain stimulation device that uses two high-frequency currents to target deep brain regions like the right amygdala
What this could lead to
If effective, TI-tACS could offer a new, non-invasive treatment option for people with depression or anxiety who haven't responded well to medication.
What could go wrong
This is an early-stage trial with a relatively small sample size, and the effects may not be large or lasting. The sham-controlled design means some participants may not receive active stimulation.

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 192 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

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 55 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: 1. Age between 18 and 55 years (inclusive), any gender; 2. Diagnosis of a single or recurrent episode of Major Depressive Disorder (MDD) or Generalized Anxiety Disorder (GAD) according to DSM-5 criteria, assessed by trained researchers using the Structured Clinical Interview for DSM-5 (SCID), without psychotic features; 3. For MDD participants: HAMD-17 score ≥14; inadequate response to stable, regular antidepressant medication for at least 1 month at an adequate dose; 4. For GAD participants: HAMA score ≥14; stable, regular medication for at least 2 months; 5. Education level: junior high school or above; adequate cognitive and language ability to understand and complete study assessments; 6. Voluntary participation with signed informed consent; ability to comply with study visits, treatment schedules, laboratory tests, and other study procedures. Exclusion Criteria: 1. History of psychiatric disorders other than MDD or GAD; 2. Pregnancy or lactation; 3. Neurologic disorders or serious systemic diseases (e.g., thyroid disease, lupus erythematosus, diabetes, hepatic or renal impairment, active infection, major trauma); 4. History of significant head injury or coma 5. Receipt of physical therapies such as electroconvulsive therapy or rTMS within the past six months before enrollment 6. Suspected or confirmed history of alcohol or substance dependence; 7. Current severe suicidal ideation or recent suicide attempt; 8. Current participation in another clinical trial or recent use of prohibited psychotropic medications; 9. Positive urine drug screening or abnormal thyroid function tests; 10. Contraindications to magnetic resonance imaging (MRI) or electroencephalography (EEG); 11. Inability to provide fully informed consent.

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Conditions

The condition(s) this trial relates to.

generalized anxiety disorder major depressive disorder

As listed by the trial registrant

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

Generalized anxiety disorder (GAD) Major depressive disorder (MDD)

How to take part

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

  1. 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 ↗

  2. 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.

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