Effect of Individualized Precise TMS on Emotional Blunting in Depression and Its Brain Imaging Mechanism

April 21, 2026 updated by: Xijing Hospital

Study on the Effect and Brain Influence Mechanism of Individualized Precise Transcranial Magnetic Stimulation Based on Image Analysis on Emotional Blunting in Depression

This study aims to explore and investigate the therapeutic effect and mechanism of individualized localization of transcranial magnetic stimulation on emotional blunting of depression, improve the understanding of the mechanism of emotional blunting of depression, order to provide new treatment methods and better curative effects for this disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Depression is a common mental illness. The traditional treatment is medication, but many patients do not respond well to medication and have side effects such as emotional blunting. emotional blunting is a numbness to both positive and negative emotions. It is estimated that about 40% to 60% of depressed patients who use serotonin (5-HT) reuptake inhibitors (SSRIs) or 5-HT and norepinephrine (NE) reuptake inhibitors (SNRIs) have varying degrees of affective retardation. Repetitive transcranial magnetic stimulation (rTMS) is a safe and non-invasive method for the treatment of depression. Its clinical efficacy is related to the accuracy of the stimulation target. How to carry out individualized accurate positioning is of great significance for improving the therapeutic effect.

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shannxi
      • Xi'an, Shannxi, China, 710032
        • XijingH

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • (1) Outpatients of all genders, aged ≥18 years and ≤65 years, right-handed, admitted to the psychosomatic Department of Xijing Hospital;

    (2) In accordance with the diagnostic criteria for the depressive disorder of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V)).

    (3) Montgomery-Asberg Depression Rating Scale (MADRS): total MADRS score ≥12;

    (4) The total score of the Oxford Depression Questionnaire (ODQ) at baseline was ≥50, and the answer to the standardized screening question of emotional blunting was "yes";

    (5) Received at least 6 weeks of monotherapy with an SSRI or SNRI prior to enrollment;

    (6) Subjects who can understand and are willing to strictly follow the clinical trial protocol to complete this study and sign informed consent.

Exclusion Criteria:

  • (1) Have a history of substance abuse within 6 months before the start of the study;

    (2) Patients with bipolar disorder and depression caused by other mental diseases (such as psychoactive substances and non-dependent substances);

    (3) Have a history of somatic severe diseases or diseases that may affect the central nervous system (such as tumors, syphilis, etc.);

    (4) Have neurological diseases or risk of seizures, such as previous brain diseases, head trauma, alcoholism, EEG abnormalities, MRI evidence of abnormal brain structure, or family history of epilepsy;

    (5) There are contraindications to MRI scanning or transcranial magnetic stimulation treatment, such as metal or electronic instruments (intracranial metal foreign bodies, cochlear implants, cardiac pacemakers, stents, and other metal foreign bodies);

    (6) Have obvious suicide risk, or have actual suicide behavior within 6 months before the start of the study;

    (7) Pregnant, breastfeeding, or planning pregnancy during the trial;

    (8) Other conditions that are not suitable for the study object in the researcher's judgment.

Study Plan

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

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TMS true stimulation group
Transcranial magnetic stimulation and medication. The stimulation parameters were 10Hz frequency and 120%MT intensity. 50 treatment sequences were given each time, with 60 stimulation times for each sequence, the sequence interval was 30 seconds, and a total of 3000 stimulation times for each treatment. The patients were treated once a day for 15 days. Medical treatment is selective serotonin reuptake inhibitors/serotonin-noradrenaline reuptake inhibitors (SSRIs/SNRIs).
Device: Transcranial magnetic stimulation
The stimulation sites of the true TMS group were mPFC-amygdala functional junction and SSRIs/SNRIs treatment, while the sham TMS group was treated with reversed magnetic head sham stimulation and SSRIs/SNRIs treatment.
Other Names:
  • SSRIs/SNRIs
Sham Comparator: TMS sham stimulation group
Sham stimulation and medication. The pseudo-stimulation method was to flip the magnetic head at 90 degrees with the scalp, The stimulation parameters were 10Hz frequency and 120%MT intensity. 50 treatment sequences were given each time, with 60 stimulation times for each sequence, the sequence interval was 30 seconds, and a total of 3000 stimulation times for each treatment. The patients were treated once a day for 15 days. Medical treatment is selective serotonin reuptake inhibitors/serotonin-noradrenaline reuptake inhibitors (SSRIs/SNRIs).
Device: Transcranial magnetic stimulation
The stimulation sites of the true TMS group were mPFC-amygdala functional junction and SSRIs/SNRIs treatment, while the sham TMS group was treated with reversed magnetic head sham stimulation and SSRIs/SNRIs treatment.
Other Names:
  • SSRIs/SNRIs

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from Baseline on Oxford Depression Questionnaire scores during treatment and at each follow-up point.
Time Frame: At baseline, at the end of treatment on day 7, at the end of treatment on day 15, 2 weeks after treatment, 4 weeks after treatment, and 8 weeks after treatment
The Oxford Depression Questionnaire(ODQ) is a relatively new tool for assessing emotional retardation, a self-rating scale.It includes three sections and 26 questions, focusing on the emotional experience of patients in the past week.Each question is scored on a 5-point scale from 1 (disagree) to 5 (agree). And summarized into a score for each dimension and a total score (total score range: 26-130). The higher the value on ODQ, the higher the level of emotional blunting.
At baseline, at the end of treatment on day 7, at the end of treatment on day 15, 2 weeks after treatment, 4 weeks after treatment, and 8 weeks after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes from Baseline on Montgomery-Asberg Depression Rating Scale scores or other clinical scales during treatment and at each follow-up point.
Time Frame: At baseline,at the end of treatment on day 7, at the end of treatment on day 15, 2 weeks after treatment, 4 weeks after treatment, and 8 weeks after treatment
There are 10 items in the Montgomery-Asberg Depression Rating Scale（MADRS）, and each item is divided into 6 levels according to the identity level, with a score of 0-6 points. The total score of patients is 0-60. The higher the score of patients, the more severe the depression.
At baseline,at the end of treatment on day 7, at the end of treatment on day 15, 2 weeks after treatment, 4 weeks after treatment, and 8 weeks after treatment
Changes of MRI from baseline to the end of 15 day treatment period.
Time Frame: Before treatment, 15 days
Before and after treatment, MRI is performed for each patient to measure the blood oxygen level of each brain region, from which the functional connectivity between brain regions could be statistically obtained, and then the differences of the functional connectivity before and treatment are compared.
Before treatment, 15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Actual)

October 30, 2024

Study Completion (Actual)

November 30, 2024

Study Registration Dates

First Submitted

September 13, 2022

First Submitted That Met QC Criteria

September 25, 2022

First Posted (Actual)

September 27, 2022

Study Record Updates

Last Update Posted (Actual)

April 23, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XJLL-KY20222175

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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