Authors
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Shandong Mental Health Center -More
Category
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Primary study
Registry of Trials»Chinese Clinical Trial Register
Year
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2026
INTERVENTION: TMS Group:Before stimulation, three‐dimensional T1‐weighted structural magnetic resonance images of the subjects were collected, and the left dorsolateral prefrontal lobe (l‐DLPFC) was located as the stimulation target in combination with the Nanjing Vishee robot navigation system. With the aid of a navigation system combined with electromyography (EMG) detection, the resting motor threshold of the first dorsal interosseous muscle was determined: the minimum stimulation intensity at which at least 5 out of 10 consecutive stimulations can induce a motor evoked potential greater than 50µV is the RMT. Subsequently, intermittent theta burst stimulation was applied to the left dorsolateral prefrontal lobe at 100% RMT intensity. Stimulation parameters: Burst frequency 50Hz, stimulation for 2 seconds with an 8‐second interval as one cycle; A single treatment involves a total of 1,800 pulses, lasting approximately 10 minutes. Four treatments are carried out daily (a total of 7,200 pulses per day), with an interval of no less than one hour between each session. The treatment was carried out 5 days a week for 2 consecutive weeks, with a total of 40 interventions.;Acupuncture‐TMS Group:The operation of TMS is the same as above. Acupuncture points selected: Baihui, Shenting, bilateral Liver Shu, Spleen Shu, Kidney Shu, Hegu, Zusanli, Sanyinjiao, Taichong. Operation: The patient assumes a prone sitting position. Local disinfection of the acupoints is routinely carried out, and a disposable acupuncture needle of 0.30mm×40mm is selected. Baihui: Flat puncture 0.5‐0.8 cun; Shenting: Insert 0.5 to 0.8 cun horizontally; Feishu: 0.5 to 0.8 cun of oblique puncture; Pishu: Insert 0.5 to 0.8 cun obliquely. Shenshu: Insert a direct puncture at 0.5 to 1.0 cun. Hegu: Insert 0.5 to 1.0 cun direc CONDITION: major depressive disorder PRIMARY OUTCOME: Hamilton Depression Rating Scale; SECONDARY OUTCOME: Hamilton Anxiety Rating Scale;Children's Depression Inventory;Somatic Symptom Disorder‐B Criteria Scale;Patient Health Questionnaire‐15;Structural MRI;Functional MRI;Arterial spin labeling perfusion imaging ;Diffusion Tensor Imaging;N‐back Task;Stroop Color‐Word Interference Task;Balloon Analog Risk Task;Stop‐Signal Task;Wisconsin Card Sorting Test;Serum biomarkers such as BDNF, APLP1, HDAC3, FGF2, IL‐6, and TNF‐a; INCLUSION CRITERIA: Inclusion criteria for adolescent patients with depressive injury: (1) Diagnosed with major depressive disorder according to the criteria of the Fifth Edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM‐5) of the United States; (2) It meets the diagnostic criteria for "depression" in the "Diagnostic Efficacy Standards for Diseases and Syndromes in Traditional Chinese Medicine". (3) Age: 11 to 20 years old; (4) No intellectual impairment or other mental disorders, and able to cooperate in completing the relevant scales and cognitive tests of this study; (5) Obtain the consent of the patient and his/her legal guardian and have them sign the informed consent form. 2. Inclusion criteria for the control group: (1) Age: 11 to 20 years old; (2) After mental examination, there is no intellectual impairment and it does not meet any of the criteria for mental impairment as listed in the Fifth Edition of the Diagnostic and Statisti
Epistemonikos ID: 61a46285ced9b9eb5c2c7c8a0f6a92761364d2f2
First added on: Aug 10, 2026