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

Primary Purpose

Depression

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Transcranial magnetic stimulation
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring emotional blunting, transcranial magnetic stimulation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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), The current major depressive episode (MDE) must be confirmed using the Mini International Neuropsychiatric Interview (MINI).

    (3) The patient's current MDE time was less than 12 months;

    (4) Montgomery-Asberg Depression Rating Scale (MADRS): total MADRS score ≥22 and ≤28;

    (5) 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";

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

    (7) 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.

Sites / Locations

  • XijingHRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

TMS true stimulation group

TMS sham stimulation group

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Changes from Baseline on Oxford Depression Questionnaire scores during treatment and at each follow-up point.
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.

Secondary Outcome Measures

Changes from Baseline on Montgomery-Asberg Depression Rating Scale scores or other clinical scales during treatment and at each follow-up point.
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.
Changes of MRI from baseline to the end of 15 day treatment period.
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.

Full Information

First Posted
September 13, 2022
Last Updated
December 26, 2022
Sponsor
Xijing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05555940
Brief Title
Effect of Individualized Precise TMS on Emotional Blunting in Depression and Its Brain Imaging Mechanism
Official Title
Study on the Effect and Brain Influence Mechanism of Individualized Precise Transcranial Magnetic Stimulation Based on Image Analysis on Emotional Blunting in Depression
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
emotional blunting, transcranial magnetic stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TMS true stimulation group
Arm Type
Experimental
Arm Description
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).
Arm Title
TMS sham stimulation group
Arm Type
Sham Comparator
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Transcranial magnetic stimulation
Other Intervention Name(s)
SSRIs/SNRIs
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes from Baseline on Oxford Depression Questionnaire scores during treatment and at each follow-up point.
Description
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.
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
Secondary Outcome Measure Information:
Title
Changes from Baseline on Montgomery-Asberg Depression Rating Scale scores or other clinical scales during treatment and at each follow-up point.
Description
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.
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
Title
Changes of MRI from baseline to the end of 15 day treatment period.
Description
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.
Time Frame
Before treatment, 15 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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), The current major depressive episode (MDE) must be confirmed using the Mini International Neuropsychiatric Interview (MINI). (3) The patient's current MDE time was less than 12 months; (4) Montgomery-Asberg Depression Rating Scale (MADRS): total MADRS score ≥22 and ≤28; (5) 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"; (6) Received at least 6 weeks of monotherapy with an SSRI or SNRI prior to enrollment; (7) 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yuyu Zhang
Phone
+8615535849017
Email
782861599@qq.com
Facility Information:
Facility Name
XijingH
City
Xi'an
State/Province
Shannxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
HuaNing WANG, PhD
Email
xskzhu@fmmu.edu.cn

12. IPD Sharing Statement

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

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