Ameliorating cognitive control in patients with binge eating disorder by electrical brain stimulation: study protocol of the randomized controlled ACCElect pilot trial

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).