Transcranial Direct Current Stimulation Interventions for Subthreshold Depressive Symptoms in Young Individuals.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- The effect of tDCS in alleviating subthreshold depressive symptoms
研究概览
简要总结
The purpose of this study is to assess the mechanisms of the effect of transcranial direct current stimulation (tDCS) in alleviating subthreshold depressive symptoms in young individuals, and individualized outcome prediction is carried out.
详细描述
After being informed about the study and potential risks, all participants providing written informed consent will undergo screening to determine eligibility for study entry. On day 0, participants who meet the eligibility requirements will be randomized in a double-blind manner (participant and investigator) in a 1:1:1 ratio to receive tDCS targeting the left dorsolateral prefrontal cortex (lDLPFC), tDCS targeting the right ventrolateral prefrontal cortex (rVLPFC), or Sham stimulation (10 sessions in 2 weeks). At baseline, after 2 weeks of stimulation, and at follow-up after 1 month and 3 months, participants will be assessed for brain network function, depressive symptoms, emotional status and social interactions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •1) Be between the ages of 12-25;
- •2) is right-handed on the Edinburgh Handedness Inventory;
- •3) 2-4 of the 9 depressive symptoms defined by the American Diagnostic and Statistical Manual of Diseases, Fifth Edition (DSM-5), lasting more than 1 week; or more than 5 depressive symptoms lasting more than 1 week but less than 2 weeks (i.e., not meeting criteria for a major depressive episode) (by DSM-5 Clinical Semi-Definitive Interview (K-SADS-PL) (Gilbody et al., 2017, JAMA);
- •4) Hamilton Depression Scale (HAMD-24) 24 points≥ 8 points, < 24 points;
- •5) Gender is not limited;
- •6) Subjects and their families voluntarily participate and sign the informed consent form.
排除标准
- •1) Individuals with the following diagnoses according to DSM-5: psychiatric disorders due to organic diseases, substance-related and addictive disorders, neurodevelopmental disorders, schizophrenia spectrum and other psychotic disorders, bipolar disorder (assessed by K-SADS-PL);
- •2) Have two or more DSM-V-defined manic symptoms for 4 days but do not meet the criteria for hypomania or meet the DSM-V defined criteria for hypomanic symptoms for only 2-3 days;
- •3) Severe or unstable physical illness;
- •4) have a moderate or higher risk of suicide (as assessed by the Columbia Suicide Severity Scale);
- •5) Received transcranial direct current stimulation in the past three months (continuous intervention time: >2 weeks);
- •6) Contraindications to transcranial direct current stimulation, such as brain implants, personal or family history of epilepsy;
- •7) Magnetic resonance scanning is contraindicated, such as in vivo metal implants.
研究组 & 干预措施
lDLPFC tdcs stimulation group
The current is 2mA, duration is 1200s, fade in 30s, fade out 30s, anode is on the F3, cathode is on the FP2.
干预措施: tdcs lDLPFC (Device)
rVLPFC tdcs stimulation group
The current is 2mA, duration is 1200s, fade in 30s, fade out 30s, anode is on the F6, cathode is on the FP1.
干预措施: tdcs rVLPFC (Device)
Sham group
The current only persist in the fisrt 30s, duration is 1200s, fade in 30s, fade out 30s, anode is on the F3/F6, cathode is on the FP2/1.
干预措施: Sham (Device)
结局指标
主要结局
The effect of tDCS in alleviating subthreshold depressive symptoms
时间窗: 2 weeks, 1 month and 3 months
In young individuals with subthreshold depressive symptoms, we used a latent growth model to test whether 10 trials of tDCS for stimulation of lDLPFC or rVLPFC had immediate and sustained (1 \& 3 months follow-up) effects on altered depressive symptoms, LPFC-DMN function regulation, positive and negative emotional processing. The latent growth curve model can fit the data well at multiple time points and analyze the correlation of the rate of change of multiple variables. We will measure participants' emotions using the original word score that has been pre-experimentally confirmed, and use the Dynamic Causal Modelling to calculate the resting-state functional regulation of LPFC to DMN (rsFC intensity from LPFC to DMN). We randomized young individuals 1:1:1 to lDLPFC, rVLPFC, and pseudo-stimulation (sham) to test the tDCS effect.
次要结局
- Neuroaffective mechanisms of tDCS in alleviating subthreshold depressive symptoms(2 weeks, 1 month and 3 months)
- To predict the individual effect of tDCS in alleviating subthreshold depressive symptoms(2 weeks, 1 month and 3 months)
研究者
Kangguang Lin
Professor
Guangzhou Psychiatric Hospital