tDCS in People With Subthreshold Depression
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: Personalized Experimental Transcranial Direct Current Stimulation (tDCS), Sham Transcranial Direct Current Stimulation (tDCS), Conventional Experimental Transcranial Direct Current Stimulation (tDCS).
- Кому может быть актуально
- Состояния в реестре: Subthreshold Depression. Базовые параметры: от 18 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
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Не всё понятно в терминах? Прочитайте наш гид для пациентов →
Официальное название
Personalised Transcranial Direct Current Stimulation to Reduce Daily Loneliness in People With Subthreshold Depression
Обзор
This study evaluates the effects of multi-session transcranial direct current stimulation on loneliness, mood and depressiveness in people with subthreshold depression.
Подробное описание
Depression-prone individuals will be invited and allocated to three groups, either the personalised transcranial direct current stimulation (tDCS) group, the conventional tDCS group, or the sham control group. After screening and at baseline prior to the tDCS sessions, participants will complete tests and questionnaires on depression symptoms, loneliness and mood. Eligible participants will also be invited to receive functional magnetic resonance imaging (MRI) in a 3-Tesla MRI scanner. There will be a maximum of 10 sessions to be completed after the screening and baseline measures. For both personalised tDCS group and the conventional tDCS group, tDCS with 2 milliampere (mA) intensity will be delivered for 20 minutes in each session. For sham control group, the protocol will be similar, except that the stimulation only happens in the first 30 seconds in each session. Especially for participants allocated to the personalised tDCS group, the stimulation site for each individual in this group may vary, depending on their brain activations and connectivity. The anodal stimulation sites for participants allocated to the conventional tDCS group and the sham control group will be F3 within the left DLPFC. Immediately after and also 3-months after completing all the tDCS sessions, participants will be invited to complete again tests and questionnaires on depressive symptoms in addition to loneliness and mood. Eligible participants will also be invited to receive functional MRI scanning in the 3T MRI scanner again. Participants will also be prompted to self-report daily their loneliness and mood levels throughout the study.
Вмешательства
- Устройство Personalized Experimental Transcranial Direct Current Stimulation (tDCS)
This study will deliver tDCS sessions for a maximum of ten sessions in two weeks' time. Participants will receive 20 minutes of active stimulation with a 2mA intensity over personalized brain regions based on the particular neural correlates of socio-affective processing. - Устройство Sham Transcranial Direct Current Stimulation (tDCS)
This study will deliver tDCS sessions for a maximum of ten sessions in two weeks' time. Participants assigned to the sham control group will only receive 30 seconds of active stimulation. - Устройство Conventional Experimental Transcranial Direct Current Stimulation (tDCS)
This study will deliver tDCS sessions for a maximum of ten sessions in two weeks' time. Participants will receive 20 minutes of active stimulation with a 2mA intensity with anode placed over F3.
Первичные конечные точки
- Changes in self-reported loneliness [Срок оценки: From baseline to after the last tDCS session; from baseline to 3 months after the last tDCS session]
Вторичные конечные точки (4)
- Changes in depressive symptoms [Срок оценки: From baseline to after the last tDCS session; from baseline to 3 months after the last tDCS session]
- Changes in anxiety symptoms [Срок оценки: From baseline to after the last tDCS session; from baseline to 3 months after the last tDCS session]
- Changes in self-reported mood [Срок оценки: From baseline to after the last tDCS session; from baseline to 3 months after the last tDCS session]
- Changes in brain activation and connectivity [Срок оценки: From baseline to after the last tDCS session; from baseline to 3 months after the last tDCS session]
Критерии участия
Критерии включения
- No histories of learning impairment, major psychiatric disorders including Major Depressive Disorder or neurological disorders
- At least primary school education
- Subthreshold depression
Критерии исключения
- On medication or treatments within 2 weeks prior to the beginning of the study that would affect the individual's brain, cognitive and affective functions
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 Education University of Hong Kong — Гонконг
Идентификаторы
NCT: NCT06517121 · 2023-2024-0048