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

NCT ID: NCT05555940

Last Updated: 2024-02-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2024-06-30

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

Transcranial magnetic stimulation

Intervention Type: DEVICE

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.

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).

Group Type: SHAM_COMPARATOR

Transcranial magnetic stimulation

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

SSRIs/SNRIs

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)).

(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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xijing Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

XijingH

Xi'an, Shannxi, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yuyu Zhang

Role: CONTACT

782861599@qq.com

+8615535849017

Facility Contacts

HuaNing WANG, PhD

Role: primary

xskzhu@fmmu.edu.cn

References

Zhang Y, Tang N, Lei L, Lv R, Zhang Y, Liu N, Chen H, Cai M, Wang H. Efficacy of functional magnetic resonance imaging-guided personalized repetitive transcranial magnetic stimulation (fMRI-rTMS) in depressive patients with emotional blunting: study protocol for a randomized controlled trial. Trials. 2024 Feb 21;25(1):134. doi: 10.1186/s13063-024-07976-3.

Reference Type: DERIVED

PMID: 38383418 (View on PubMed)

Other Identifiers

XJLL-KY20222175

Identifier Type: -

Identifier Source: org_study_id