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Recruiting NCT07319143

The Effect of Transcranial Direct Current Stimulation (tDCS) in Improving Emotion Health

No phase Interventional Subthreshold Depression Positive Emotions Negative Emotions Anhedonia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Transcranial Direct Current Stimulation, Sham tDCS.
Who it may be relevant to
Registry conditions: Subthreshold Depression, Positive Emotions, Negative Emotions, Anhedonia. Basic parameters: 18 years — 35 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hong Kong
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Utilizing Transcranial Direct Current Stimulation (tDCS) to Alleviate Subthreshold Depression Via Distinct Positive and Negative Emotion Pathways

Overview

The goal of this clinical trial is to investigate how transcranial direct current stimulation (tDCS) affects emotion functions in young adults aged 18-35 from the local community, including both male and female participants. The main question\[s\] it aims to answer are: * Does tDCS improve emotional functions, such as mood regulation and motivation, in individuals with subthreshold depression (StD)? * Can tDCS enhance emotional regulation compared to a sham stimulation (placebo)? Researchers will compare participants receiving tDCS on either the left dorsolateral prefrontal cortex (lDLPFC) or right ventrolateral prefrontal cortex (rVLPFC) with those receiving sham stimulation to see if tDCS has a stronger effect on emotional functions. Participants will: * Complete online and in-person screening to assess depressive symptoms using the Chinese version of the Beck Depression Inventory II (C-BDI-II) and be selected based on their depressive symptoms (C-BDI-II score ≥ 13). * Be randomly assigned to one of three groups: lDLPFC tDCS, rVLPFC tDCS, or Sham control group (1:1:1 ratio). * Receive 10 sessions of tDCS or Sham tDCS over 2 weeks, with each session lasting 20 minutes. * Complete assessments at baseline, post-intervention, 1-month follow-up, and 3-month follow-up, with each assessment lasting 2-2.5 hours. This includes questionnaires and perform emotional and cognitive tasks.

Interventions

  • Device Transcranial Direct Current Stimulation
    TDCS is a non-invasive, safe, inexpensive, convenient and effective method to modulate brain and emotion functions. During tDCS, a mild electric current is passed between the anodal and cathodal electrodes on the scalp, which respectively excites and inhibits local and downstream neuronal activity, as well as modulating interregional connectivity strength. Compared to other neurostimulation methods such as Transcranial Magnetic Stimulation, tDCS side effects tend to be milder and transient, even
  • Device Sham tDCS
    The sham tDCS delivers actual stimulation for 30 seconds only, while providing similar psychological perceptions to participants as the real intervention. Thus, the sham tDCS serves as an active control condition to the tDCS interventions.

Primary outcome measures

  • Depressive symptoms [Time frame: Baseline (Day 1), Post-Intervention (Day 15), 1-Month Follow-up (Day 45), 3-Month Follow-up (Day 105)]
Secondary outcome measures (12)
  • Affective trait [Time frame: Baseline (Day 1), Post-Intervention (Day 15), 1-Month Follow-up (Day 45), 3-Month Follow-up (Day 105)]
  • Anhedonia severity [Time frame: Baseline (Day 1), Post-Intervention (Day 15), 1-Month Follow-up (Day 45), 3-Month Follow-up (Day 105)]
  • Anhedonia symptoms [Time frame: Baseline (Day 1), Post-Intervention (Day 15), 1-Month Follow-up (Day 45), 3-Month Follow-up (Day 105)]
  • Behavioural motivation trait [Time frame: Baseline (Day 1), Post-Intervention (Day 15), 1-Month Follow-up (Day 45), 3-Month Follow-up (Day 105)]
  • Emotion regulation function [Time frame: Baseline (Day 1), Post-Intervention (Day 15), 1-Month Follow-up (Day 45), 3-Month Follow-up (Day 105)]
  • Coping to adversity [Time frame: Baseline (Day 1), Post-Intervention (Day 15), 1-Month Follow-up (Day 45), 3-Month Follow-up (Day 105)]
  • Reward sensitivity [Time frame: Baseline (Day 1), Post-Intervention (Day 15), 1-Month Follow-up (Day 45), 3-Month Follow-up (Day 105)]
  • Apathy symptom [Time frame: Baseline (Day 1), Post-Intervention (Day 15), 1-Month Follow-up (Day 45), 3-Month Follow-up (Day 105)]
  • Perceived loneliness [Time frame: Baseline (Day 1), Post-Intervention (Day 15), 1-Month Follow-up (Day 45), 3-Month Follow-up (Day 105)]
  • Stress level [Time frame: Baseline (Day 1), Post-Intervention (Day 15), 1-Month Follow-up (Day 45), 3-Month Follow-up (Day 105)]
  • Emotion ratings of words [Time frame: Baseline (Day 1), Post-Intervention (Day 15), 1-Month Follow-up (Day 45), 3-Month Follow-up (Day 105)]
  • Instrumental behavioural motivation [Time frame: Baseline (Day 1), Post-Intervention (Day 15), 1-Month Follow-up (Day 45), 3-Month Follow-up (Day 105)]

Eligibility criteria

Inclusion criteria

  • Age 18-35 years
  • Fluency in Cantonese or Mandarin
  • Normal or corrected-to-normal vision and hearing
  • IQ > 75% Quantile in Raven's SPM
  • At least 9 years of formal education
  • Right-handedness

Exclusion criteria

  • Past or current major physical illness or psychiatric disorders
  • Use of psychotropic medication in the past 6 months
  • Pregnancy (for women)
  • Any condition that prevents safe tDCS use (e.g., brain injury, implants)
  • Previous participation in neuromodulation in the past 3 months

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Hong Kong · 1 center
  • The University of Hong Kong — Hong Kong

Identifiers

NCT: NCT07319143 · EA240670 · 17600425

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗