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NCT Number: NCT06294184

TDCS Interventions for Subthreshold Depressive Symptoms in Young Individuals.

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.

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Key information

Age range

12 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Guangzhou Brain hospital(Guangzhou Huiai Hospital)

Guangzhou, Guangdong, 510370, China

Location status: Recruiting

Location contact

Kangguang Lin, M.D;Ph.D

CONTACT

[email protected]

86-13560360144

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

tdcs lDLPFC

Device

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

Device

The current is 2mA, duration is 1200s, fade in 30s, fade out 30s, anode is on the F6, cathode is on the FP1.

SHAM

Device

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.

Primary outcomes

  1. The effect of tDCS in alleviating subthreshold depressive symptoms

    Time frame: 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 outcomes

  1. Neuroaffective mechanisms of tDCS in alleviating subthreshold depressive symptoms

    Time frame: 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.

  2. To predict the individual effect of tDCS in alleviating subthreshold depressive symptoms

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Kangguang Lin, M.D;Ph.D

CONTACT

[email protected]

86-02081268189

Sponsors and collaborators

Lead sponsor

Guangzhou Psychiatric Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Mar 5, 2024
Registry last updated
Dec 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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