Efficacy of High-precision Transcranial Direct Current Stimulation on Anxiety Disorders
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Hamilton Anxiety Scale
研究概览
简要总结
- Current research has found that tDCS has a positive effect on improving the negative attention bias of AD patients, and this study uses HD-tDCS intervention to improve the cognitive function and neural mechanisms of AD patients in the OFC to provide a theoretical basis for AD neural mechanism research. Verify Hypothesis 1: HD-tDCS cathodal stimulation of the left OFC reduces the excitability of this region, modulates its connectivity with the attentional function network, and thus changes the emotional experience of social threat.
- Currently, there is no consensus on the stimulation parameters for tDCS in the treatment of AD, and more evidence is needed to prove and explore. It is hoped that the HD-tDCS intervention protocol will become an effective treatment method for improving cognitive function and clinical symptoms in AD patients. Hypothesis 2: The HD-tDCS with intensified stimulation parameters (2mA, twice a day, with a 20-minute interval, for 5 consecutive days) has an impact on the main and secondary clinical variables of AD patients.
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, Care Provider)
入排标准
- 年龄范围
- 20 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Meet the DSM-5 AD diagnostic criteria;
- •The Chinese version of the Brief International Neuropsychiatric Interview (MINI) screening meets the diagnosis;
- •Age: 18-55 years old;
- •The patient participated voluntarily, obtained the consent of the family members, and signed the informed consent form;
- •Scale score criteria: 14 points on the Hamilton Anxiety Scale (HAMA) and 17 points on the Hamilton Depression Scale (HAMD).
排除标准
- •Neurological diseases or other psychiatric disorders;
- •severe somatic diseases;
- •received medical treatment including medication, psychotherapy, electroconvulsive therapy, and physical therapy within the first half months of enrollment;
- •tDCS examination contraindications, such as intracranial metal or electronic implants, skull plate, or other skull implants.
- •Pregnancy and lactation.
研究组 & 干预措施
High-definition transcranial direct current stimulation
HD-tDCS stimulated AD left OFC (2 mA, 20 minutes, cathode electrode placed in the Fp 1 area, and the remaining four positive electrodes placed AF3, AF7, Afz, Fpz, forming a circular 41 focused electric field mode for stimulation, twice a day, 20 minutes interval for 5 days)
干预措施: High-definition transcranial direct current stimulation (Other)
High-definition transcranial direct current stimulation pseudo-stimulation control group
The treatment parameters of the electrode were the same as the test group, the stimulation current rose to the same 2 mA current in the test group within 30 seconds, and the pre-stimulation for 1 minute, then gradually to 0 mA.
干预措施: High-definition transcranial direct current stimulation pseudo-stimulation control group (Other)
结局指标
主要结局
Hamilton Anxiety Scale
时间窗: 1 week
HAMA was assessed at baseline and late 5 days after treatment by a professionally trained physician (non-trial intervention) to understand the effectiveness of treatment. Clinical efficacy evaluation criteria: 75% was recovered, 50% was significant, 25% was effective, and \<25% was invalid.
次要结局
未报告次要终点
研究者
Chun Wang
professor
Nanjing Medical University