通过脑电刺激改善暴饮暴食症患者的认知控制：随机对照ACCElect试点试验的研究方案
Ameliorating cognitive control in patients with binge eating disorder by electrical brain stimulation: study protocol of the randomized controlled ACCElect pilot trial.
作者信息
Giel Katrin E, Schag Kathrin, Martus Peter, Max Sebastian M, Plewnia Christian
机构信息
Department of Psychosomatic Medicine and Psychotherapy, Medical University Hospital Tübingen, Eberhard Karls University Tübingen, Osianderstr. 5, 72076, Tübingen, Germany.
Center of Excellence for Eating Disorders, Tübingen, Germany.
出版信息
J Eat Disord. 2022 Feb 19;10(1):26. doi: 10.1186/s40337-022-00544-7.
BACKGROUND
The current first-line treatment for binge eating disorder (BED), which is psychotherapy, is moderately effective in terms of abstinence from binge-eating. Neurobiological evidence suggests that people affected by BED show difficulties along the spectrum of impulsivity, including inhibitory control impairments and highlights the potential of novel treatment approaches directly targeting inhibitory control, including cognitive training approaches and non-invasive brain stimulation.
METHODS
ACCElect is a prospective, randomized controlled pilot trial investigating a novel, food-related inhibitory control training combined with transcranial direct current stimulation (tDCS). 40 patients with BED will be randomly assigned to receive the training either combined with verum or with sham stimulation (control condition). The inhibitory control training is based on principles of the antisaccade paradigm and comprises six training sessions over two weeks. Core aims are the investigation of feasibility and clinically relevant effects of a tDCS-enhanced inhibitory control training in BED patients and the establishment of a data basis for a larger efficacy trial. The primary clinical endpoint is binge-eating (BE) frequency in terms of changes in BE episodes four weeks after treatment termination as compared to baseline. Key secondary outcomes comprise ED pathology and general psychopathology, inhibitory control capacities, quality of life as well as acceptability and satisfaction with the intervention.
DISCUSSION
The results of the present trial will contribute to the development of novel neurobiologically informed treatment approaches for patients suffering from BED. Trial registration The ACCElect trial was prospectively registered on October 1, 2020, under the registration number NCT04572087 at ClinicalTrials.gov ( https://clinicaltrials.gov/ct2/show/NCT04572087 ).
背景
暴饮暴食症（BED）目前的一线治疗方法是心理治疗，在戒除暴饮暴食方面有一定效果。神经生物学证据表明，受BED影响的人在冲动性方面存在困难，包括抑制控制受损，并突出了直接针对抑制控制的新型治疗方法的潜力，包括认知训练方法和非侵入性脑刺激。
方法
ACCElect是一项前瞻性、随机对照试验，研究一种新型的、与食物相关的抑制控制训练结合经颅直流电刺激（tDCS）。40名BED患者将被随机分配接受联合真刺激或假刺激（对照条件）的训练。抑制控制训练基于反扫视范式的原则，包括在两周内进行六次训练。核心目标是研究tDCS增强的抑制控制训练在BED患者中的可行性和临床相关效果，并为更大规模的疗效试验建立数据基础。主要临床终点是治疗终止四周后与基线相比暴饮暴食（BE）发作频率的变化。关键次要结果包括进食障碍病理学和一般精神病理学、抑制控制能力、生活质量以及对干预的可接受性和满意度。
讨论
本试验结果将有助于为BED患者开发新的基于神经生物学的治疗方法。试验注册ACCElect试验于2020年10月1日在ClinicalTrials.gov（https://clinicaltrials.gov/ct2/show/NCT04572087）上进行了前瞻性注册，注册号为NCT04572087。
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