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针对患有精神疾病青少年的情绪调节的脑刺激:一项临床跨诊断、随机、三盲和假对照神经治疗试验的研究方案。

Brain Stimulation for Emotion Regulation in Adolescents With Psychiatric Disorders: Study Protocol for a Clinical-Transdiagnostical, Randomized, Triple-Blinded and Sham-Controlled Neurotherapeutic Trial.

作者信息

Konicar Lilian, Prillinger Karin, Klöbl Manfred, Lanzenberger Rupert, Antal Andrea, Plener Paul L

机构信息

Department of Child and Adolescent Psychiatry, Medical University of Vienna, Vienna, Austria.

Department of Psychiatry and Psychotherapy, Medical University of Vienna, Vienna, Austria.

出版信息

Front Psychiatry. 2022 Apr 25;13:840836. doi: 10.3389/fpsyt.2022.840836. eCollection 2022.

DOI:10.3389/fpsyt.2022.840836
PMID:35546931
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9082670/
Abstract

BACKGROUND

Anxiety, conduct and depressive disorders represent three highly prevalent psychiatric conditions in adolescents. A shared underpinning of these disorders is a shortcoming in emotion regulation, connected to the functioning of the ventromedial prefrontal cortex. Thus, an intervention able to target the suggested neural correlate seems to be highly desirable, aiming to hinder a maladaptive development of emotion regulation abilities and chronification of associated psychiatric disorders. As transcranial direct current stimulation (tDCS) was repeatedly demonstrated as a safe and non-invasive method to modulate specific brain activity, research is in demand to evaluate neurotherapeutic applications in adolescents with psychiatric disorders.

METHOD

This transdiagnostic, randomized, triple-blind and sham-controlled clinical neurostimulation trial primary aims to investigate if emotion regulation abilities are increased after tDCS in adolescents with psychiatric disorders. Secondly, disorder-specific changes in the anxiety, depression or conduct disorder will be investigated, as well as changes in quality of life, and cognitive and emotional functioning after tDCS intervention. We will include 108 adolescents with psychiatric disorders, displaying a substantial deficit in emotion regulation. Of these, one third each has to be primarily diagnosed with a depressive, anxiety or conduct disorder, respectively. Participants will be randomized to the experimental group ( = 54) receiving real anodal tDCS, or to the control group ( = 54) receiving sham tDCS. Brain stimulation will be applied for 20 min on five consecutive days twice targeting the ventromedial prefrontal cortex (vmPFC). Changes in emotion regulation, together with changes in disorder-specific clinical symptoms will be recorded by multi-informant psychological ratings. To inspect changes in behavior and gaze, computerized tasks and an eye tracker system will be used. Changes in brain responses to emotional and cognitive stimuli will be examined with three functional magnetic resonance imaging (fMRI) paradigms. In addition, a resting state MRI will be acquired to investigate possible changes in brain connectivity.

DISCUSSION

By investigating "emotion regulation" as transdiagnostic treatment target, this project is oriented toward the Research Domain Criteria framework with a dimensional view on mental illness. The study aims at investigating the potential of tDCS as non-invasive intervention for depressive, anxiety and conduct disorders in adolescents and broadening the scientific foundation for its clinical application.

CLINICAL TRIAL REGISTRATION

The study is ongoing and has been registered in the German Registry of Clinical Trials (DRKS-ID: DRKS00025601X) on the 28.06.2021.

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e39b/9082670/ef03105e7680/fpsyt-13-840836-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e39b/9082670/faca5fed9905/fpsyt-13-840836-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e39b/9082670/ef03105e7680/fpsyt-13-840836-g0002.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e39b/9082670/faca5fed9905/fpsyt-13-840836-g0001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/e39b/9082670/ef03105e7680/fpsyt-13-840836-g0002.jpg
摘要

背景

焦虑症、品行障碍和抑郁症是青少年中三种高度常见的精神疾病。这些疾病的一个共同潜在因素是情绪调节方面的缺陷,这与腹内侧前额叶皮层的功能有关。因此,一种能够针对所提出的神经关联物的干预措施似乎非常必要,旨在阻碍情绪调节能力的适应不良发展以及相关精神疾病的慢性化。由于经颅直流电刺激(tDCS)已被反复证明是一种调节特定大脑活动的安全且非侵入性的方法,因此需要开展研究来评估其在患有精神疾病的青少年中的神经治疗应用。

方法

这项跨诊断、随机、三盲和假对照的临床神经刺激试验的主要目的是研究tDCS是否能提高患有精神疾病的青少年的情绪调节能力。其次,将研究焦虑症、抑郁症或品行障碍的特定疾病变化,以及tDCS干预后生活质量、认知和情绪功能的变化。我们将纳入108名患有精神疾病且情绪调节存在严重缺陷的青少年。其中,三分之一的人必须分别被初步诊断为患有抑郁症、焦虑症或品行障碍。参与者将被随机分为接受真正阳极tDCS的实验组(n = 54)或接受假tDCS的对照组(n = 54)。大脑刺激将连续五天每天进行20分钟,两次靶向腹内侧前额叶皮层(vmPFC)。情绪调节的变化以及特定疾病临床症状的变化将通过多信息者心理评分来记录。为了检查行为和注视的变化,将使用计算机化任务和眼动追踪系统。将通过三种功能磁共振成像(fMRI)范式来检查大脑对情绪和认知刺激的反应变化。此外,将采集静息态MRI以研究大脑连接性的可能变化。

讨论

通过将“情绪调节”作为跨诊断治疗目标进行研究,该项目以精神疾病的维度视角为导向,遵循研究领域标准框架。该研究旨在调查tDCS作为青少年抑郁症、焦虑症和品行障碍的非侵入性干预措施的潜力,并拓宽其临床应用的科学基础。

临床试验注册

该研究正在进行中,已于2021年6月28日在德国临床试验注册中心(DRKS-ID:DRKS00025601X)注册。

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