Department of Child and Adolescent Psychiatry, Psychosomatics and Psychotherapy, University Hospital Frankfurt, Goethe University, Deutschordenstr.50, 60528, Frankfurt, Germany.
Institute of Medical Informatics and Statistics (IMIS), Kiel University, Brunswiker Str. 10, 24105, Kiel, Germany.
Trials. 2021 Apr 6;22(1):248. doi: 10.1186/s13063-021-05172-1.
Autism spectrum disorder (ASD) is characterized by impaired social communication and interaction, and stereotyped, repetitive behaviour and sensory interests. To date, there is no effective medication that can improve social communication and interaction in ASD, and effect sizes of behaviour-based psychotherapy remain in the low to medium range. Consequently, there is a clear need for new treatment options. ASD is associated with altered activation and connectivity patterns in brain areas which process social information. Transcranial direct current stimulation (tDCS) is a technique that applies a weak electrical current to the brain in order to modulate neural excitability and alter connectivity. Combined with specific cognitive tasks, it allows to facilitate and consolidate the respective training effects. Therefore, application of tDCS in brain areas relevant to social cognition in combination with a specific cognitive training is a promising treatment approach for ASD.
A phase-IIa pilot randomized, double-blind, sham-controlled, parallel-group clinical study is presented, which aims at investigating if 10 days of 20-min multi-channel tDCS stimulation of the bilateral tempo-parietal junction (TPJ) at 2.0 mA in combination with a computer-based cognitive training on perspective taking, intention and emotion understanding, can improve social cognitive abilities in children and adolescents with ASD. The main objectives are to describe the change in parent-rated social responsiveness from baseline (within 1 week before first stimulation) to post-intervention (within 7 days after last stimulation) and to monitor safety and tolerability of the intervention. Secondary objectives include the evaluation of change in parent-rated social responsiveness at follow-up (4 weeks after end of intervention), change in other ASD core symptoms and psychopathology, social cognitive abilities and neural functioning post-intervention and at follow-up in order to explore underlying neural and cognitive mechanisms.
If shown, positive results regarding change in parent-rated social cognition and favourable safety and tolerability of the intervention will confirm tDCS as a promising treatment for ASD core-symptoms. This may be a first step in establishing a new and cost-efficient intervention for individuals with ASD.
The trial is registered with the German Clinical Trials Register (DRKS), DRKS00014732 . Registered on 15 August 2018.
This study protocol refers to protocol version 1.2 from 24 May 2019.
自闭症谱系障碍（ASD）的特征是社交沟通和互动受损，以及刻板、重复的行为和感官兴趣。迄今为止，没有有效的药物可以改善 ASD 中的社交沟通和互动，行为为基础的心理治疗的效果大小仍处于低到中等范围。因此，显然需要新的治疗选择。ASD 与处理社交信息的大脑区域的激活和连通性模式改变有关。经颅直流电刺激（tDCS）是一种向大脑施加弱电流以调节神经兴奋性并改变连通性的技术。与特定的认知任务相结合，可以促进和巩固各自的训练效果。因此，将 tDCS 应用于与社会认知相关的大脑区域，并结合特定的认知训练，是 ASD 的一种有前途的治疗方法。
呈现了一项 IIa 期前瞻性随机、双盲、假对照、平行组临床试验，旨在研究 10 天 2.0 mA 双侧颞顶联合（TPJ）多通道 tDCS 刺激与基于计算机的换位思考、意图和情绪理解认知训练相结合，是否可以提高 ASD 儿童和青少年的社会认知能力。主要目标是描述从基线（刺激前 1 周内）到干预后（刺激后 7 天内）父母评定的社交反应的变化，并监测干预的安全性和耐受性。次要目标包括评估干预结束后 4 周（干预结束后 4 周）时父母评定的社交反应变化、其他 ASD 核心症状和精神病理学变化、干预后的社会认知能力和神经功能变化以及随访时的变化，以探索潜在的神经和认知机制。
如果显示出关于父母评定的社会认知变化的积极结果和干预的良好安全性和耐受性，则 tDCS 将被确认为 ASD 核心症状的有前途的治疗方法。这可能是为 ASD 个体建立新的、具有成本效益的干预措施的第一步。
该试验在德国临床试验注册处（DRKS）注册，DRKS00014732。注册于 2018 年 8 月 15 日。
本研究方案指的是 2019 年 5 月 24 日的第 1.2 版。
