Precision Transcranial Magnetic Stimulation for Depression Based on Orbital Frontal Cortex-habenula Circuitry

February 16, 2025 updated by: Xijing Hospital

Safety and Efficacy Study of Precise Transcranial Magnetic Stimulation for Depression Based on Individualized Functional Connectivity Localization of Orbital Frontal Cortex-habenula

Thirty depressed patients will be recruited to select individualized transcranial magnetic stimulation targets based on individual orbital frontal cortex and habenula functional activity connectivity for 10 or 20 treatments to assess the efficacy and safety of this intervention

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

30

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 Contact

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710000

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

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Gender is not limited, age 18～60 years old;
  • Comply with the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) of the United States of America;
  • Hamilton rating scale for depression (HAMD) 17-item score ≥ 18;
  • The medication/psychotherapy received by the subject prior to the start of the study remained stable for at least 4 weeks .

Exclusion Criteria:

  • History of serious somatic diseases or diseases that may affect the central nervous system (e.g., tumors, syphilis, etc.);
  • Neurological disorders or risk of seizures, such as previous craniosynostosis, head trauma, alcoholism, abnormal electroencephalograms, MRI evidence of structural abnormalities in the brain, or family history of epilepsy;
  • Patients with bipolar disorder and depression due to other psychiatric disorders (e.g., psychoactive and non-dependent substances);
  • Contraindications to MRI scanning or transcranial magnetic stimulation therapy, such as metal or electronic devices placed in the body (intracranial metal foreign bodies, cochlear implants, pacemakers and stents and other metal foreign bodies), space phobia;
  • People with psychotic symptoms requiring joint application of antipsychotic drugs;
  • Those with high risk of suicide, or those who have already committed suicide or serious self-injury behavior requiring urgent intervention;
  • Those who are pregnant, breastfeeding or planning to become pregnant during the trial;
  • Other conditions judged by the investigator to be unsuitable as research subjects.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Individualized transcranial magnetic stimulation
Device: transcranial magnetic stimulation
Individualized transcranial magnetic stimulation of targets based on the association between the orbitofrontal cortex and the functional activity of the habenula .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores from baseline to treatment day 10
Time Frame: Baseline and treatment day 10

The Montgomery-Asberg Depression Rating Scale (MADRS) is a widely used clinical assessment tool designed to measure the severity of depressive symptoms.The MADRS consists of 10 items, each of which addresses a different aspect of depression, such as low mood, loss of interest, sleep disorders, appetite, concentration, fatigue, inability to feel pleasure, pessimistic thinking, and suicidal ideation. Each item is scored according to the severity of symptoms, ranging from 0 to 6, with a total score ranging from 0-60, with higher scores indicating more severe depressive symptoms.

Change = (treatment day 10 Score -Baseline Score).
Baseline and treatment day 10

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hamilton Depression Scale（HAMD-17）scores from baseline to 28 days after the end of treatment
Time Frame: Baseline and 28 days after the end of treatment

Hamilton Depression Scale（HAMD-17） is a commonly used clinical evaluation standard for the severity of depressive symptoms. There are 17 items in total, which can be scored before and after treatment to evaluate the severity of the disease and the treatment effect.Possible scores range from 0 to 52 and the higher the score, the worse the symptom.

Change = (28 days after the end of treatment Score -Baseline Score).
Baseline and 28 days after the end of treatment
Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores from baseline to 28 days after the end of treatment
Time Frame: Baseline and 28 days after the end of treatment

The Montgomery-Asberg Depression Rating Scale (MADRS) is a widely used clinical assessment tool designed to measure the severity of depressive symptoms.The MADRS consists of 10 items, each of which addresses a different aspect of depression, such as low mood, loss of interest, sleep disorders, appetite, concentration, fatigue, inability to feel pleasure, pessimistic thinking, and suicidal ideation. Each item is scored according to the severity of symptoms, ranging from 0 to 6, with a total score ranging from 0-60, with higher scores indicating more severe depressive symptoms.

Change = (28 days after the end of treatment Score -Baseline Score).
Baseline and 28 days after the end of treatment
Change in Hamilton Anxiety Scale scores from baseline to treatment day 10
Time Frame: Baseline and treatment day 10

Hamilton Anxiety Scale (HAMA）is suitable for assessing the severity of anxiety symptoms. It has 14 items and adopts a 5-level scoring method of 0-4 points.Possible scores range from 0 to 56 and the higher the score, the worse the symptom.

Change = (treatment day 10 Score -Baseline Score).
Baseline and treatment day 10
Change in Hamilton Anxiety Scale scores from baseline to 28 days after the end of treatment
Time Frame: Baseline and 28 days after the end of treatment

Hamilton Anxiety Scale (HAMA）is suitable for assessing the severity of anxiety symptoms. It has 14 items and adopts a 5-level scoring method of 0-4 points.Possible scores range from 0 to 56 and the higher the score, the worse the symptom.

Change = (28 days after the end of treatment Score -Baseline Score).
Baseline and 28 days after the end of treatment
Change in Hamilton Depression Scale（HAMD-17）scores from baseline to treatment day 10
Time Frame: Baseline and treatment day 10

Hamilton Depression Scale（HAMD-17） is a commonly used clinical evaluation standard for the severity of depressive symptoms. There are 17 items in total, which can be scored before and after treatment to evaluate the severity of the disease and the treatment effect.Possible scores range from 0 to 52 and the higher the score, the worse the symptom.

Change = (treatment day 10 Score -Baseline Score).
Baseline and treatment day 10
Change in Pittsburgh sleep quality index (PSQI) scores from baseline to treatment day 10
Time Frame: Baseline and treatment day 10
The Pittsburgh Sleep Quality Index is suitable for patients with sleep disorders to evaluate the quality of their sleep, as well as for the general population to assess the quality of their sleep. The scale consists of 9 questions, of which the first 4 are fill-in-the-blanks and the last 5 are multiple-choice (question 5 contains 10 sub-questions) Change = (treatment day 10 Score -Baseline Score).
Baseline and treatment day 10
Change in Pittsburgh sleep quality index (PSQI) scores from baseline to 28 days after the end of treatment
Time Frame: Baseline and 28 days after the end of treatment
The Pittsburgh Sleep Quality Index is suitable for patients with sleep disorders to evaluate the quality of their sleep, as well as for the general population to assess the quality of their sleep. The scale consists of 9 questions, of which the first 4 are fill-in-the-blanks and the last 5 are multiple-choice (question 5 contains 10 sub-questions) Change = (28 days after the end of treatment Score -Baseline Score).
Baseline and 28 days after the end of treatment
Change in Snaith-Hamilton Pleasure Scale scores from baseline to treatment day 10
Time Frame: Baseline and treatment day 10

The Snaith-Hamilton Pleasure Scale (SHAPS) is a self-report questionnaire used to assess pleasure deficits (anhedonia).The SHAPS scale consists of 14 entries asking subjects to rate their level of agreement with pleasure responses in a number of pleasurable situations on a 4-point scale. The measure taken is the subject's situation in the most recent period of time. Pleasure experience is measured in four domains: interests/recreation, social interactions, sensory experiences, and food/drink. The scale has good reliability and validity in normal as well as clinical populations. Each entry is rated on a 4-point scale, with "strongly agree, agree, disagree, and strongly disagree" scoring from 1 to 4, respectively.

Change = (treatment day 10 Score -Baseline Score).
Baseline and treatment day 10
Change in Snaith-Hamilton Pleasure Scale scores from baseline to 28 days after the end of treatment
Time Frame: Baseline and 28 days after the end of treatment

The Snaith-Hamilton Pleasure Scale (SHAPS) is a self-report questionnaire used to assess pleasure deficits (anhedonia).The SHAPS scale consists of 14 entries asking subjects to rate their level of agreement with pleasure responses in a number of pleasurable situations on a 4-point scale. The measure taken is the subject's situation in the most recent period of time. Pleasure experience is measured in four domains: interests/recreation, social interactions, sensory experiences, and food/drink. The scale has good reliability and validity in normal as well as clinical populations. Each entry is rated on a 4-point scale, with "strongly agree, agree, disagree, and strongly disagree" scoring from 1 to 4, respectively.

Change = (28 days after the end of treatment Score -Baseline Score).
Baseline and 28 days after the end of treatment

Collaborators and Investigators

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

Sponsor

Xijing Hospital

Investigators

  • Principal Investigator: Huaning Wang, 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 (Estimated)

March 1, 2025

Primary Completion (Estimated)

April 15, 2025

Study Completion (Estimated)

March 1, 2026

Study Registration Dates

First Submitted

February 16, 2025

First Submitted That Met QC Criteria

February 16, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 16, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KY20242429

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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