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Идёт набор NCT07636694

Effects of Concurrent and Consecutive Repetitive Transcranial Magnetic Stimulation (rTMS) and Cognitive Bias Modification (CBM)

Без фазы С лечением Depression - Major Depressive Disorder

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: TMS, Cognitive Bias Modification, Sham TMS.
Кому может быть актуально
Состояния в реестре: Depression - Major Depressive Disorder. Базовые параметры: Без ограничений · 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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Обзор

The goal of this study is to learn whether combining repetitive transcranial magnetic stimulation (rTMS) with a computerized behavioral intervention (imagery cognitive bias modification, CBM-I) reduces negative interpretation bias and mild-to-moderate depressive symptoms. The study will also examine neural changes in the dorsolateral prefrontal cortex (DLPFC) and whether timing of interventions affects outcomes. The main questions it aims to answer are: Does active TMS reduce negative interpretation bias and depressive symptoms more than sham TMS? Is delivering CBM-I concurrently with TMS more effective than delivering it consecutively (separate sessions) at reducing negative bias and depressive symptoms? Do combined rTMS + CBM-I approaches produce greater neural changes and improved cognitive control over self-referential interpretation than controls? Researchers will compare active TMS versus sham TMS, and concurrent versus consecutive delivery of CBM-I, to test effects on negative bias and depressive symptoms. Participants will: Receive either active rTMS or sham TMS targeting the DLPFC Complete imagery CBM-I sessions either concurrently with TMS or in separate (consecutive) sessions Undergo assessments of negative interpretation bias, depressive symptoms, and neural measures before and after the intervention

Вмешательства

  • Устройство TMS
    The rTMS group will receive 10 Hz stimulation to the left DLPFC at an intensity of 120% of the resting motor threshold of the right abductor pollicis brevis (APB) muscle with 4 sec trains and 11 sec intertrain intervals for 3000 pulses.Specifically in our study, we combine both intervention, but applying them concurrently and consecutively between groups.
  • Поведенческое Cognitive Bias Modification
    Imagery CBM-I focuses on 2 cognitive aspects, mental imagery and interpretation. Participants will be presented with scenarios in which they have to imagine themselves to be in and practice constructing positive endings or interpretations for them.
  • Устройство Sham TMS
    The TMS coil will be rotated 90 degrees, and will not be delivering active stimulation to the participant. The intensity will be set to 30 and the TMS device will be active, generating enough sound effect but no real stimulation for sham control.

Первичные конечные точки

  • Cognitive Bias [Срок оценки: "From enrollment to the end of treatment at 4 weeks"]
  • Depressive Symptoms [Срок оценки: "From enrollment to the end of treatment at 4 weeks"]
  • Resting State functional MRI [Срок оценки: "From enrollment to the end of treatment at 4 weeks"]
Вторичные конечные точки (8)
  • Subjective Well Being [Срок оценки: "From enrollment to the end of treatment at 4 weeks"]
  • Sleep Quality [Срок оценки: "From enrollment to the end of treatment at 4 weeks"]
  • Anxiety Symptoms [Срок оценки: "From enrollment to the end of treatment at 4 weeks"]
  • Structural MRI [Срок оценки: "From enrollment to the end of treatment at 4 weeks"]
  • Rumination Symptoms [Срок оценки: "From enrollment to the end of treatment at 4 weeks"]
  • Anhedonia Symptoms [Срок оценки: "From enrollment to the end of treatment at 4 weeks"]
  • Cognitive Measures-Attention [Срок оценки: "From enrollment to the end of treatment at 4 weeks"]
  • Cognitive Measures-Attention [Срок оценки: "From enrollment to the end of treatment at 4 weeks"]

Критерии участия

Критерии включения

  • Aged 18 years or above
  • Right-handed
  • Normal or corrected hearing and vision
  • Obtained primary education or above
  • Able to fluently read and understand Chinese
  • Beck's Depression Inventory-II (BDI-II) score ranging from 14-28

Критерии исключения

  • History of severe physical disease, brain organic diseases, and neurological disorders (e.g., dementia, brain injury, stroke, epilepsy, Parkinson's disease)
  • History of substance use/ dependence/ withdrawal
  • Participants with intellectual disability based on IQ scores
  • Participants with contraindications for rTMS such as foreign metal bodies, implant devices (cochlear implants) or history (personal or family) of seizure
  • Participants who are not suitable to be scanned by magnetic resonance imaging (MRI) machine (e.g., claustrophobic, pregnant, metal in the body, hearing aids)

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Факторный дизайн
Маскирование
Простое слепое
Основная цель
Лечение

Центры проведения

Гонконг · 1 центр
  • InnoCentre of Clinical Neuropsychology, The University of Hong Kong — Quarry Bay

Идентификаторы

NCT: NCT07636694 · EA230645

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗