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Идёт набор NCT07319143

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

Без фазы С лечением Subthreshold Depression Positive Emotions Negative Emotions Anhedonia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Transcranial Direct Current Stimulation, Sham tDCS.
Кому может быть актуально
Состояния в реестре: Subthreshold Depression, Positive Emotions, Negative Emotions, Anhedonia. Базовые параметры: 18 лет — 35 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Гонконг
Следующий шаг
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Официальное название

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

Обзор

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.

Вмешательства

  • Устройство 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
  • Устройство 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.

Первичные конечные точки

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

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Двойное слепое
Основная цель
Лечение

Центры проведения

Гонконг · 1 центр
  • The University of Hong Kong — Гонконг

Идентификаторы

NCT: NCT07319143 · EA240670 · 17600425

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗