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

NCT05555940 | Completed DMC

• 1 other identifier: XJLL-KY20222175
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Depression

Keywords

emotional blunting; transcranial magnetic stimulation

Outcome Measures

Primary Outcomes (1)

• 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.

  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 Outcomes (2)

• Changes from Baseline on Montgomery-Asberg Depression Rating Scale scores or other clinical scales during treatment and at each follow-up point.

  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.

  Before treatment, 15 days

Study Arms (2)

TMS true stimulation group

EXPERIMENTAL

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

TMS sham stimulation group

SHAM COMPARATOR

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

Interventions

Transcranial magnetic stimulation 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.

Also known as: SSRIs/SNRIs

TMS sham stimulation group; TMS true stimulation group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Xijing Hospital: lead

Study Sites (1)

XijingH

Xi'an, Shannxi, 710032, China

Location

Related Publications (1)

• 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.

  PMID: 38383418 DERIVED

MeSH Terms

Conditions

Depression

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 27, 2022
• Study Start: October 1, 2022
• Primary Completion: October 30, 2024
• Study Completion: November 30, 2024
• Last Updated: April 23, 2026

Record last verified: 2025-01

Locations

CN (1)