Completed

Amygdala Temporal Interference Stimulation for Depression

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Study Aim

This study aims to evaluate the effects of amygdala temporal interference stimulation on reducing depressive symptoms in individuals with depression.

What is being tested

Nervio-X

Device
Who is being recruted

Mental Disorders+1

+ Depressive Disorder, Major

+ Depressive Disorder

From 18 to 65 Years
+14 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-Controlled
Interventional
Study Start: July 2024
See protocol details

Summary

Principal SponsorRuijin Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: July 24, 2024

Actual date on which the first participant was enrolled.

This clinical trial is focused on exploring a new way to help people with depression by using a special method that stimulates a part of the brain called the right amygdala. This area is known to play a role in emotions and mood regulation. The study aims to see if this targeted brain stimulation can effectively reduce symptoms of depression. Depression is a common condition that can severely impact daily life, so finding new treatments is important to offer more options to those affected. Participants in the study will undergo a brain stimulation procedure, which carefully targets the right amygdala to potentially improve their mood and overall mental health. The study will assess the treatment's effectiveness by monitoring changes in depressive symptoms, cognitive abilities, and how well participants can perform daily activities. Safety is also a key focus, ensuring that the procedure does not pose any significant risks to the participants. By carefully measuring these outcomes, the study aims to provide valuable insights into whether this innovative approach can offer a new avenue for treating depression.

Official TitleA Multicenter, Randomized, Controlled, Double-Blind Trial on the Efficacy and Safety of Amygdala Temporal Interference Stimulation for the Treatment of Depression.
NCT06477276
Principal SponsorRuijin Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

92 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 65 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Mental DisordersDepressive Disorder, MajorDepressive DisorderMood Disorders

Criteria

5 inclusion criteria required to participate
Participants must be aged between 18 and 65, with no gender restrictions;

A diagnosis of depression made by the study physician based on the Diagnostic and Statistical Manual of Mental Disorders (DSM-5);

HAMD-17 score of 17 or higher;

Participants must not have changed their antidepressant medication regimen from 30 days prior to signing the informed consent form through the duration of the experiment;

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9 exclusion criteria prevent from participating
The researcher evaluated the individual's mental state and determined it to present a significant risk of suicidal ideation or behavior;

Pregnant or breastfeeding;

Eligible participants must not have a history of psychiatric disorders such as schizophrenia, as judged by the investigator, which may impact the evaluation of the study's efficacy;

Participants must not have a history of seizures or prior episodes of epilepsy;

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Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Experimental
5 sessions will be delivered in 3 weeks

Group II

Sham
5 sessions will be delivered in 3 weeks

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Suspended

Shanghai East Hospital

Shanghai, ChinaOpen Shanghai East Hospital in Google Maps
Suspended

Ruijin Hospital

Shanghai, China
Suspended

Tianjin Anding Hospital (Mental Health Center of Tianjin Medical University)

Tianjin, China
Completed3 Study Centers