Study on the Effect and Brain Influence Mechanism of Individualized Precise Transcranial Magnetic Stimulation Based on Image Analysis on Emotional Blunting in Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Changes from Baseline on Oxford Depression Questionnaire scores during treatment and at each follow-up point.
研究概览
简要总结
This study aims to explore and investigate the therapeutic effect and mechanism of individualized localization of transcranial magnetic stimulation on emotional blunting of depression, improve the understanding of the mechanism of emotional blunting of depression, order to provide new treatment methods and better curative effects for this disease.
详细描述
Depression is a common mental illness. The traditional treatment is medication, but many patients do not respond well to medication and have side effects such as emotional blunting. emotional blunting is a numbness to both positive and negative emotions. It is estimated that about 40% to 60% of depressed patients who use serotonin (5-HT) reuptake inhibitors (SSRIs) or 5-HT and norepinephrine (NE) reuptake inhibitors (SNRIs) have varying degrees of affective retardation. Repetitive transcranial magnetic stimulation (rTMS) is a safe and non-invasive method for the treatment of depression. Its clinical efficacy is related to the accuracy of the stimulation target. How to carry out individualized accurate positioning is of great significance for improving the therapeutic effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Outpatients of all genders, aged ≥18 years and ≤65 years, right-handed, admitted to the psychosomatic Department of Xijing Hospital;
- •(2) In accordance with the diagnostic criteria for the depressive disorder of the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V)).
- •(3) Montgomery-Asberg Depression Rating Scale (MADRS): total MADRS score ≥12;
- •(4) The total score of the Oxford Depression Questionnaire (ODQ) at baseline was ≥50, and the answer to the standardized screening question of emotional blunting was "yes";
- •(5) Received at least 6 weeks of monotherapy with an SSRI or SNRI prior to enrollment;
- •(6) Subjects who can understand and are willing to strictly follow the clinical trial protocol to complete this study and sign informed consent.
排除标准
- •(1) Have a history of substance abuse within 6 months before the start of the study;
- •(2) Patients with bipolar disorder and depression caused by other mental diseases (such as psychoactive substances and non-dependent substances);
- •(3) Have a history of somatic severe diseases or diseases that may affect the central nervous system (such as tumors, syphilis, etc.);
- •(4) Have neurological diseases or risk of seizures, such as previous brain diseases, head trauma, alcoholism, EEG abnormalities, MRI evidence of abnormal brain structure, or family history of epilepsy;
- •(5) There are contraindications to MRI scanning or transcranial magnetic stimulation treatment, such as metal or electronic instruments (intracranial metal foreign bodies, cochlear implants, cardiac pacemakers, stents, and other metal foreign bodies);
- •(6) Have obvious suicide risk, or have actual suicide behavior within 6 months before the start of the study;
- •(7) Pregnant, breastfeeding, or planning pregnancy during the trial;
- •(8) Other conditions that are not suitable for the study object in the researcher's judgment.
研究组 & 干预措施
TMS true stimulation group
Transcranial magnetic stimulation and medication. The stimulation parameters were 10Hz frequency and 120%MT intensity. 50 treatment sequences were given each time, with 60 stimulation times for each sequence, the sequence interval was 30 seconds, and a total of 3000 stimulation times for each treatment. The patients were treated once a day for 15 days. Medical treatment is selective serotonin reuptake inhibitors/serotonin-noradrenaline reuptake inhibitors (SSRIs/SNRIs).
干预措施: Transcranial magnetic stimulation (Device)
TMS sham stimulation group
Sham stimulation and medication. The pseudo-stimulation method was to flip the magnetic head at 90 degrees with the scalp, The stimulation parameters were 10Hz frequency and 120%MT intensity. 50 treatment sequences were given each time, with 60 stimulation times for each sequence, the sequence interval was 30 seconds, and a total of 3000 stimulation times for each treatment. The patients were treated once a day for 15 days. Medical treatment is selective serotonin reuptake inhibitors/serotonin-noradrenaline reuptake inhibitors (SSRIs/SNRIs).
干预措施: Transcranial magnetic stimulation (Device)
结局指标
主要结局
Changes from Baseline on Oxford Depression Questionnaire scores during treatment and at each follow-up point.
时间窗: At baseline, at the end of treatment on day 7, at the end of treatment on day 15, 2 weeks after treatment, 4 weeks after treatment, and 8 weeks after treatment
The Oxford Depression Questionnaire(ODQ) is a relatively new tool for assessing emotional retardation, a self-rating scale.It includes three sections and 26 questions, focusing on the emotional experience of patients in the past week.Each question is scored on a 5-point scale from 1 (disagree) to 5 (agree). And summarized into a score for each dimension and a total score (total score range: 26-130). The higher the value on ODQ, the higher the level of emotional blunting.
次要结局
- Changes from Baseline on Montgomery-Asberg Depression Rating Scale scores or other clinical scales during treatment and at each follow-up point.(At baseline,at the end of treatment on day 7, at the end of treatment on day 15, 2 weeks after treatment, 4 weeks after treatment, and 8 weeks after treatment)
- Changes of MRI from baseline to the end of 15 day treatment period.(Before treatment, 15 days)