tDCS Interventions for Subthreshold Depressive Symptoms in Young Individuals.

Transcranial Direct Current Stimulation Clinical Trial

Official title:

Transcranial Direct Current Stimulation Interventions for Subthreshold Depressive Symptoms in Young Individuals.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06294184
• Other study ID #: Guangzhou PH tDCS in SD
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: December 2024

Study information

• Verified date: February 2024
• Source: Guangzhou Psychiatric Hospital
• Contact: Kangguang Lin, M.D;Ph.D
• Phone: 86-02081268189
• Email: linkangguang[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: December 2024
• Est. primary completion date: November 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 12 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Subthreshold Depression
• Transcranial Direct Current Stimulation

Intervention

Device:
• tdcs lDLPFC
The current is 2mA, duration is 1200s, fade in 30s, fade out 30s, anode is on the F3, cathode is on the FP2.
• tdcs rVLPFC
The current is 2mA, duration is 1200s, fade in 30s, fade out 30s, anode is on the F6, cathode is on the FP1.
• Sham
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.

Locations

Country	Name	City	State
China	Guangzhou Brain hospital(Guangzhou Huiai Hospital)	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangzhou Psychiatric Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The effect of tDCS in alleviating subthreshold depressive symptoms	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.	2 weeks, 1 month and 3 months
Secondary	Neuroaffective mechanisms of tDCS in alleviating subthreshold depressive symptoms	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.	2 weeks, 1 month and 3 months
Secondary	To predict the individual effect of tDCS in alleviating subthreshold depressive symptoms	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.	2 weeks, 1 month and 3 months