Subthreshold Depression, Transcranial Direct Current Stimulation, Young People
Conditions
Keywords
Resting-state brain functional network, Social emotion
Brief summary
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.
Detailed description
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.
Interventions
DEVICEtdcs lDLPFC
The current is 2mA, duration is 1200s, fade in 30s, fade out 30s, anode is on the F3, cathode is on the FP2.
DEVICEtdcs rVLPFC
The current is 2mA, duration is 1200s, fade in 30s, fade out 30s, anode is on the F6, cathode is on the FP1.
DEVICESham
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.
Sponsors
Guangzhou Psychiatric Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 25 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The effect of tDCS in alleviating subthreshold depressive symptoms | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neuroaffective mechanisms of tDCS in alleviating subthreshold depressive symptoms | 2 weeks, 1 month and 3 months | We will examine the cross-sectional association between LPFC-DMN functional regulation, positive and negative emotional processing, and depressive symptoms at each time point, and test whether there is a longitudinal association between the immediate and persistent effects of tDCS on the above variables. We will use the cross-lagged structure equation model to test whether the effects of tDCS on LPFC-DMN functional regulation (neural mechanism) and positive and negative emotional processing (affective mechanism) significantly mediate the effect of tDCS on depressive symptoms (outcome variables). We will clarify the temporal sequence of mechanism-outcome effects by testing whether mechanism effects at earlier time points can prospectively predict outcome effects at subsequent time points to infer causal relationships. |
| To predict the individual effect of tDCS in alleviating subthreshold depressive symptoms | 2 weeks, 1 month and 3 months | Based on the above analysis results, we will use the Connectome-Based Predictive Model (CPM) method to construct emotional neural data models that predict individual effects. With the advantage of data fitting in machine learning methods, we will screen emotional neurovariables that are significantly related to the level and change of depressive symptoms based on the results of the above mechanism, and build a prediction model around them. We will focus on testing a machine learning model that prospectively predicts the effect of individual interventions: this model will use baseline or earlier time point data to predict the tDCS effect longitudinally at subsequent time points of individual participants. We will also integrate all variables that are cross-sectionally and vertically associated with the level and change of solitary autonomy to build a comprehensive predictive model. |
Countries
China
Contacts
Primary ContactKangguang Lin, M.D;Ph.D
Outcome results
None listed