RecruitingNot ApplicableNCT06385405

Electroencephalography-based Precise Repetitive Transcranial Magnetic Stimulation Treatment

Repetitive Transcranial Magnetic Stimulation(rTMS) Treatment Based on Personalized Modulation of Electroencephalography Promotes Symptom Remission in Major Depressive Disorder (MDD) - A Randomized Controlled Clinical Trial

Sponsor

Shanghai Mental Health Center

Enrollment

70 participants

Start Date

May 27, 2024

Study Type

INTERVENTIONAL

Conditions

Major Depressive Disorder (MDD)

Summary

This study will focus on the hypothesis that repetitive transcranial magnetic stimulation (TMS) based on EEG personalized modulation may be more effective in promoting symptomatic relief of major depressive disorder (MDD), and will rely on the platform of neuroimaging and function brain imaging of Shanghai Mental Health Center (SMHC), an authoritative institution in the field of mental health. We will eventually facilitate optimization of physical therapy for major depressive disorder (MDD).

Eligibility

Min Age: 16 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an EEG-guided (brainwave-guided) repetitive transcranial magnetic stimulation (rTMS) treatment for major depression, where brainwave patterns are used to personalize where and how brain stimulation is delivered. **You may be eligible if...** - You are between 16 and 65 years old - You have been diagnosed with Major Depressive Disorder (MDD) - Your depression score is 20 or above on the Hamilton Depression Scale - You are currently taking only one antidepressant and are willing to keep the same medication during the trial **You may NOT be eligible if...** - You have had electroconvulsive therapy (ECT) before - You have metal implants in or near your head, or a pacemaker - You have epilepsy, schizophrenia, bipolar disorder, or a history of significant head injury - You are pregnant - You have participated in another clinical trial in the past 30 days Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEIndividualized alpha frequency Transcranial Magnetic Stimulation (αTMS) Treatment

The target site for alpha frequency Transcranial Magnetic Stimulation (αTMS) was identified based on alterations in alpha band spectral connectivity, which were measured using four frontal electroencephalography (EEG) channels (F1, F3, F5, FC3) subsequent to 10Hz transcranial magnetic stimulation (TMS). Alpha band spectral connectivity refers to the degree of similarity between the spectral waveforms of the alpha band across channels. The alpha frequency stimulation rate was defined as the highest spectral peak within the alpha band ranging from 7 to 13 Hz of the target channel. Each treatment cycle consisted of 20 daily sessions over a 4-week span, and stimulation was administered for 2 seconds every minute for a total duration of 20 minutes at 80% of the individual's motor threshold.

DEVICE10Hz-frequency TMS treatment over the left dorsolateral prefrontal cortex (DLPFC)

Prefrontal Transcranial Magnetic Stimulation (TMS) therapy repeated daily over 4 weeks (20 sessions) is US Food and Drug Administration (FDA) approved for treating Major Depressive Disorder in adults who have not responded to prior antidepressant medications. The strongest evidence supports high-frequency treatment over the left dorsolateral prefrontal cortex (DLPFC). The common stimulation frequency is 10Hz. It is usually applied for a duration of 4 weeks, 5 days a week.