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

Официальное название

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

Обзор

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.

Вмешательства

• Устройство sham 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.
• Устройство accelerated 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.
• Устройство high 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.

Первичные конечные точки

• Hamilton depression scale-24 [Срок оценки: baseline]
• Hamilton depression scale-24 [Срок оценки: 5days]
• Hamilton depression scale-24 [Срок оценки: 4 weeks]

Вторичные конечные точки (12)

• Change in the score of THINC-it. [Срок оценки: Baseline]
• Change in the score of THINC-it. [Срок оценки: 5 days]
• Change in the score of THINC-it. [Срок оценки: 4 weeks]
• Change in neuroimaging using functional magnetic resonance [Срок оценки: Baseline]
• Change in neuroimaging using functional magnetic resonance [Срок оценки: 5 days]
• Change of blood factor levels [Срок оценки: baseline]
• Change of blood factor levels [Срок оценки: 5 days]
• Change of blood factor levels [Срок оценки: 4 weeks]
• Change in electroencephalogram [Срок оценки: baseline]
• Change in electroencephalogram [Срок оценки: 5 days]
• Hamilton anxiety scale [Срок оценки: baseline]
• Hamilton anxiety scale [Срок оценки: 5 days]

Критерии участия

Критерии включения

• Sign a written informed consent to participate in the trial and receive treatment;
• Major depressive disorder diagnosis;
• Hamilton depression scale (HAMD - 24) 24 total score 20 points or more;
• First episode or recurrence of depression patients, not taking psychiatric drugs;
• The han nationality, right-handed;
• Junior high school or above;

Критерии исключения

• Other organic mental disorders and mental retardation and other severe mental disorders;
• Infection, trauma, and autoimmune diseases or other possible interference test evaluation of disease;
• Alcohol and drug dependence or is being treated for a hormone drugs patients;
• Craniocerebral injury;
• Seizure or a family history of epilepsy;
• Pregnancy and lactation women;
• All landowners had a metal and MRI contraindications or MRI examination revealed abnormal brain structure.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• the First Affiliated Hospital,Zhejiang University School of Medicine — Ханчжоу

Идентификаторы

NCT: NCT05913960 · IITA20230315

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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