RecruitingNot ApplicableNCT05913960

Accelerated Intermittent Theta-Burst Stimulation Ameliorate Major Depressive Disorder by Regulating CAMKII Pathway

the Mechanism of Accelerated Intermittent Theta Burst Stimulation for Rapid Treatment of Major Depressive Disorder Based on the Prefrontal Excitation-inhibition Balance Regulated by CAMKII Pathway


Sponsor

First Affiliated Hospital of Zhejiang University

Enrollment

90 participants

Start Date

Feb 9, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Major depressive disorder(MDD) is a complex and heterogeneous mental disorder. Repeated transcranial magnetic stimulation (rTMS), as a non-invasive neuroregulatory technique, has shown a promising function in the treatment of depression. Theta-burst transcranial magnetic stimulation (TBS) model significantly shortened the duration of physical therapy treatment, and iTBS under the accelerated model (The latter is referred to as aiTBS)showed promising therapeutic effect. However, whether aiTBS has a better and faster curative effect in the first untreated or recurrent unmedicated MDD patients and the mechanism of its alleviation of depressive symptoms remains unclarified. This project intends to verify changes in CAMKII levels, CAMKII molecules and GABA receptors in brain-derived exosomes in normal controls and patients who received sham, aiTBS and high-frequency (10Hz) stimulation respectively. Neuroimaging and TMS-EEG were used to pinpoint the target of stimulation and to record the changes of brain waves before and after treatment in real time. To clarify the neurobiological mechanism of aiTBS rapidly improving depression, and to provide a new strong evidence for clinical transcranial magnetic stimulation for accurate treatment of MDD patients.


Eligibility

Min Age: 12 YearsMax Age: 45 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an accelerated form of TMS (transcranial magnetic stimulation — a non-invasive brain treatment) to see if it relieves major depression by affecting a specific brain signaling pathway (CaMKII). It delivers multiple TMS sessions per day over a shorter period. **You may be eligible if...** - You have been diagnosed with major depressive disorder - Your depression score is 20 or higher (Hamilton scale) - You are experiencing a first episode or relapse of depression - You are not currently taking psychiatric medications **You may NOT be eligible if...** - You have a history of seizures or epilepsy - You have metal implants in your head or a pacemaker - You are currently taking psychiatric medications - You are pregnant or breastfeeding - You have a diagnosis of bipolar disorder or schizophrenia 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

DEVICEsham stimulation

The parameters in the sham arm will be as above with the internal randomization of the device internally switching to sham in a blinded fashion.

DEVICEaccelerated intermittent theta burst stimulation

Participants in the active stimulation group will receive the accelerated intermittent TBS to left DLPFC. The L-DLPFC will be targeted utilizing the neuronavigation system. Stimulation intensity will be standardized at 90% of RMT. Stimulation will be delivered to the L-DLPFC using an NTK-TMS-II100 TMS device,is compatible with the Brainsight TMS navigation system.

DEVICEhigh frequency stimulation

Participants in the active stimulation group will receive the high frequnency stimulation to left DLPFC. The L-DLPFC will be targeted utilizing the neuronavigation system. Stimulation intensity will be standardized at 90% of RMT. Stimulation will be delivered to the L-DLPFC using an NTK-TMS-II100 TMS device,is compatible with the Brainsight TMS navigation system.


Locations(1)

the First Affiliated Hospital,Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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NCT05913960


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