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Идёт набор NCT06658795

Treating Loneliness In The Older Adult With Depression With tDCS

Без фазы С лечением Major Depressive Disorder Loneliness

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 (tDCS) on the Left DLPFC, Transcranial direct current stimulation (tDCS) on the right VLPFC, Sham stimulation group.
Кому может быть актуально
Состояния в реестре: Major Depressive Disorder, Loneliness. Базовые параметры: 60 лет — 80 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
Китай
Следующий шаг
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Официальное название

Effects of Transcranial Direct Current Stimulation on Loneliness in Older Adults With Depression: A Randomized Controlled Trial

Обзор

High loneliness is prevalent among older adults and is a significant risk factor for major depression and low recovery rates in patients. Current interventions for loneliness are limited. Previous research has demonstrated a link between loneliness, negative social emotions, and reduced resting-state functional connectivity in the lateral prefrontal cortex (LPFC) and the default mode network (DMN). Transcranial direct current stimulation (tDCS) has shown promise in enhancing emotional regulation and connectivity, potentially alleviating loneliness in older adults with depression.

Подробное описание

Loneliness is a pervasive issue among older adults, significantly increasing the risk of major depression and contributing to low recovery rates in affected individuals. Despite its widespread impact, current interventions aimed at alleviating loneliness remain limited and often ineffective. Research has revealed a strong connection between feelings of loneliness, negative social emotions, and decreased resting-state functional connectivity in key brain regions, particularly the lateral prefrontal cortex (LPFC) and the default mode network (DMN). These findings suggest that the neural underpinnings of loneliness may be targeted to improve emotional well-being.

Transcranial direct current stimulation (tDCS) emerges as a promising intervention in this context, as it has been shown to enhance emotional regulation and improve functional connectivity within these neural networks. By applying low electrical currents to specific brain areas, tDCS may help mitigate feelings of loneliness, thereby fostering a greater sense of social connection among older adults with depression.

Objectives Evaluate the Effects of Repeated tDCS on Loneliness Levels: This trial aims to systematically assess how repeated sessions of tDCS influence loneliness in older adults with major depressive disorder. By comparing these groups, we hope to understand the differential impacts of tDCS on loneliness, taking into account the potential confounding effects of depression.

Elucidate the Neuro-Emotional Mechanisms: A key objective is to uncover the neuro-emotional mechanisms that underlie the effects of tDCS on loneliness. This involves examining changes in neural activity and connectivity patterns in the LPFC and DMN, as well as tracking shifts in negative social emotions that may accompany improvements in loneliness. Understanding these mechanisms could enhance the efficacy of tDCS as an intervention.

Develop Predictive Models for Individualized Treatment Outcomes: Another important aim of this trial is to create predictive models that utilize neuro-emotional data to tailor treatment approaches for individuals. By identifying specific neural and emotional markers that correlate with positive outcomes from tDCS, we can move toward more personalized interventions, potentially improving recovery rates and overall mental health in older adults with depression facing loneliness.

This trial represents a significant step toward addressing the critical issue of loneliness in older adults with depression, with the potential to offer a novel and effective intervention strategy that integrates neurobiology and emotional health.

Вмешательства

  • Устройство Transcranial direct current stimulation (tDCS) on the Left DLPFC
    The tDCS parameters were set to a current of 2mA for a single session lasting 20 minutes. For stimulating the lDLPFC, the positive electrode was placed at position F3, and the negative electrode was placed in the right supraorbital area/FP2 (e.g., Dubreuil-Vall et al., 2021, Biol Psychiatry: CNNI).
  • Устройство Transcranial direct current stimulation (tDCS) on the right VLPFC
    The tDCS parameters were set to a current of 2mA for a single session lasting 20 minutes. Based on the EEG 10-20 international system, the positive electrode for stimulating the rVLPFC was placed at position F6, while the negative electrode was placed in the left supraorbital area/FP1 (e.g., He et al., 2020, Psychol Med)
  • Устройство Sham stimulation group
    The electrode positions were randomized to match those of the rVLPFC or lDLPFC groups, but the stimulation only lasted for the first 30 seconds.

Первичные конечные точки

  • Change in loneliness levels from baseline measured by the UCLA Loneliness Scale from baseline [Срок оценки: 2 weeks, 1.5 months and 3.5 months]
Вторичные конечные точки (12)
  • Change in Emotional and Motivational Ratings from baseline [Срок оценки: 2 weeks, 1.5 months and 3.5 months]
  • changes in Social Participation Levels from baseline [Срок оценки: 2 weeks, 1.5 months and 3.5 months]
  • changes in Social Motivation from baseline [Срок оценки: 2 weeks, 1.5 months and 3.5 months]
  • changes in Social Network from baseline [Срок оценки: 2 weeks, 1.5 months and 3.5 months]
  • changes in Emotional Regulation from baseline [Срок оценки: 2 weeks, 1.5 months and 3.5 months]
  • changes in Affective Traits from baseline [Срок оценки: 2 weeks, 1.5 months and 3.5 months]
  • changes in Reward Sensitivity from baseline [Срок оценки: 2 weeks, 1.5 months and 3.5 months]
  • changes in Depressive Symptoms from baseline [Срок оценки: 2 weeks, 1.5 months and 3.5 months]
  • changes in Resting-State Functional Connectivity from baseline [Срок оценки: 2 weeks, 1.5 months and 3.5 months]
  • Change in social support from baseline [Срок оценки: 2 weeks, 1.5 months and 3.5 months]
  • changes in Emotion Coping from baseline [Срок оценки: 2 weeks, 1.5 months and 3.5 months]
  • changes in Incentive-Driven Behavioural Tendencies from baseline [Срок оценки: 2 weeks, 1.5 months and 3.5 months]

Критерии участия

Критерии включения

  • High loneliness (UCLA Loneliness Scale > 43).
  • Diagnosis of major depressive disorder confirmed by the Structured Clinical Interview for DSM-5 Disorders.
  • absence of suicidal ideation (Hamilton Depression Scale item 3 score ≤ 1).

Критерии исключения

  • Severe neurological diseases.
  • Bipolar disorder, schizophrenia, addiction, or impulse control disorders.
  • Contraindications for tDCS or MRI (e.g., metal implants).
  • Presence of suicidal ideation.

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
Тройное слепое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Guangzhou Brain Hospital — Гуанчжоу

Публикации

  • Dubreuil-Vall L, Gomez-Bernal F, Villegas AC, Cirillo P, Surman C, Ruffini G, Widge AS, Camprodon JA. Transcranial Direct Current Stimulation to the Left Dorsolateral Prefrontal Cortex Improves Cognitive Control in Patients With Attention-Deficit/Hyperactivity Disorder: A Randomized Behavioral and Neurophysiological Study. Biol Psychiatry Cogn Neurosci Neuroimaging. 2021 Apr;6(4):439-448. doi: 10. PMID 33549516
  • He Z, Liu Z, Zhao J, Elliott R, Zhang D. Improving emotion regulation of social exclusion in depression-prone individuals: a tDCS study targeting right VLPFC. Psychol Med. 2020 Dec;50(16):2768-2779. doi: 10.1017/S0033291719002915. Epub 2019 Oct 16. PMID 31615594

Идентификаторы

NCT: NCT06658795 · 2024-17

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗