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Personalized Brain Functional Sector-guided rTMS Therapy Over Different Targets for Treatment-resistant Depression

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What is being tested

active rTMS stimulating

Device
Who is being recruted

Mental Disorders+2

+ Depressive Disorder, Major

+ Depressive Disorder

From 18 to 65 Years
+21 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: February 2024
See protocol details

Summary

Principal SponsorChangping Laboratory
Study ContactMeiling Li, Ph.D.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 20, 2024

Actual date on which the first participant was enrolled.

The study focuses on improving treatment for individuals with depression who have not responded well to standard therapies. It examines the use of a therapy called repetitive transcranial magnetic stimulation (rTMS), which stimulates specific parts of the brain, specifically the dorsolateral and ventromedial prefrontal cortex areas. These areas are linked with mood regulation, and their precise stimulation may help relieve symptoms of depression. The research aims to determine the most effective brain targets for rTMS to ensure better outcomes for patients. By identifying personalized targets within the brain, the study hopes to enhance the effectiveness of depression treatments and address the limitations of current therapies. Participants in the study will first go through a screening process to confirm they are eligible. Once selected, they will begin treatment, which involves receiving rTMS therapy targeting one of 40 specific sites in the brain over a two-week period. The treatment does not involve surgery or medication changes, as participants will maintain their usual treatment routines during the study. To assess the therapy's impact, patients will be monitored during the treatment and for a week after the treatment ends. The study is carefully designed to ensure safety and to explore how different brain sites respond to the therapy, thus aiding in the development of more effective and personalized interventions for treating depression.

Official TitlePersonalized Brain Functional Sector-guided rTMS Therapy Over Different Targets for Treatment-resistant Depression
NCT06255561
Principal SponsorChangping Laboratory
Study ContactMeiling Li, Ph.D.
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

75 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 DisordersDepressive Disorder, Treatment-Resistant

Criteria

7 inclusion criteria required to participate
Meet the diagnostic criteria of DSM-5(Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition) for depression disorder without psychotic symptoms, and currently experiencing a recurrence episode.

Total HAMD17 score ≥20 and total MADRS score ≥20 before randomization.

Hospitalized/outpatient patients aged 18-65 years (inclusive), male or female.

Inadequate response to at least one antidepressant trial of adequate doses and duration.

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14 exclusion criteria prevent from participating
Meet DSM-5 diagnostic criteria for other mental disorders (such as schizophrenia spectrum disorders, bipolar and related disorders, neurodevelopmental disorders, neurocognitive disorders, or depressive disorders due to substances and/or medications, depressive disorders due to other medical problems, etc.);

Patients with a cardiac pacemaker, cochlear implant, or other metal foreign body and any electronic equipment implanted in the body, patients with claustrophobia and other contraindications to magnetic resonance scanning, and patients with contraindications to rTMS treatment;

History of epilepsy (presence of at least 2 uninduced seizures more than 24 hours apart, or diagnosis of the epileptic syndrome, or seizures within the past 12 months); Or currently received medications or other treatments that will lower the seizure threshold;

History of ECT, rTMS, and light therapy within 3 months;

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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

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
2 sessions with 1800 pulses per session and 50min inter-session interval of active rTMS will deliver to the assigned target.

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.
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