Safety and Efficacy Study of Precise Transcranial Magnetic Stimulation for Depression Based on Individualized Functional Connectivity Localization of Orbital Frontal Cortex-habenula
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores from baseline to treatment day 10
研究概览
简要总结
Thirty depressed patients will be recruited to select individualized transcranial magnetic stimulation targets based on individual orbital frontal cortex and habenula functional activity connectivity for 10 or 20 treatments to assess the efficacy and safety of this intervention
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Gender is not limited, age 18～60 years old;
- •Comply with the diagnostic criteria for major depressive disorder in the Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5) of the United States of America;
- •Hamilton rating scale for depression (HAMD) 17-item score ≥ 18;
- •The medication/psychotherapy received by the subject prior to the start of the study remained stable for at least 4 weeks .
排除标准
- •History of serious somatic diseases or diseases that may affect the central nervous system (e.g., tumors, syphilis, etc.);
- •Neurological disorders or risk of seizures, such as previous craniosynostosis, head trauma, alcoholism, abnormal electroencephalograms, MRI evidence of structural abnormalities in the brain, or family history of epilepsy;
- •Patients with bipolar disorder and depression due to other psychiatric disorders (e.g., psychoactive and non-dependent substances);
- •Contraindications to MRI scanning or transcranial magnetic stimulation therapy, such as metal or electronic devices placed in the body (intracranial metal foreign bodies, cochlear implants, pacemakers and stents and other metal foreign bodies), space phobia;
- •People with psychotic symptoms requiring joint application of antipsychotic drugs;
- •Those with high risk of suicide, or those who have already committed suicide or serious self-injury behavior requiring urgent intervention;
- •Those who are pregnant, breastfeeding or planning to become pregnant during the trial;
- •Other conditions judged by the investigator to be unsuitable as research subjects.
研究组 & 干预措施
Individualized transcranial magnetic stimulation
干预措施: transcranial magnetic stimulation (Device)
结局指标
主要结局
Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores from baseline to treatment day 10
时间窗: Baseline and treatment day 10
The Montgomery-Asberg Depression Rating Scale (MADRS) is a widely used clinical assessment tool designed to measure the severity of depressive symptoms.The MADRS consists of 10 items, each of which addresses a different aspect of depression, such as low mood, loss of interest, sleep disorders, appetite, concentration, fatigue, inability to feel pleasure, pessimistic thinking, and suicidal ideation. Each item is scored according to the severity of symptoms, ranging from 0 to 6, with a total score ranging from 0-60, with higher scores indicating more severe depressive symptoms. Change = (treatment day 10 Score -Baseline Score).
次要结局
- Change in Montgomery-Asberg Depression Rating Scale (MADRS) scores from baseline to 28 days after the end of treatment(Baseline and 28 days after the end of treatment)
- Change in Hamilton Anxiety Scale scores from baseline to treatment day 10(Baseline and treatment day 10)
- Change in Hamilton Anxiety Scale scores from baseline to 28 days after the end of treatment(Baseline and 28 days after the end of treatment)
- Change in Hamilton Depression Scale（HAMD-17）scores from baseline to treatment day 10(Baseline and treatment day 10)
- Change in Hamilton Depression Scale（HAMD-17）scores from baseline to 28 days after the end of treatment(Baseline and 28 days after the end of treatment)
- Change in Pittsburgh sleep quality index (PSQI) scores from baseline to treatment day 10(Baseline and treatment day 10)
- Change in Pittsburgh sleep quality index (PSQI) scores from baseline to 28 days after the end of treatment(Baseline and 28 days after the end of treatment)
- Change in Snaith-Hamilton Pleasure Scale scores from baseline to treatment day 10(Baseline and treatment day 10)
- Change in Snaith-Hamilton Pleasure Scale scores from baseline to 28 days after the end of treatment(Baseline and 28 days after the end of treatment)