Ameliorating Cognitive Control in Binge Eating Disorder by Electrical Brain Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Binge eating frequency
研究概览
简要总结
There is evidence that impairment of impulse regulation is involved in the development and maintenance of eating disorders, especially in Binge Eating Disorder (BED). BED is characterized by recurrent episodes of binge eating with experienced loss of control over eating. Controlling impulsive behaviour, cognitive flexibility, planning and decision making are key abilities of impulse regulation. Some of these impaired cognitive functions are linked to decreased activity of certain brain regions. Transcranial direct current stimulation (tDCS) is a well-established method to alter brain activity. In the current project, we explore if a computer-assisted training programme for patients with BED that is combined with tDCS is feasible and able to ameliorate impulse regulation and impulsive eating behaviour. We hypothesize that the cognitive training programme with additional tDCS will result in a greater decrease of BED symptoms and a stronger increase in impulse regulation skills compared with the cognitive training programme without tDCS by using a placebo stimulation.
详细描述
Patients with BED form a subgroup of obese patients with a disinhibited eating pattern that is associated with major impairments in cognitive control. The dorsolateral prefrontal cortex (dlPFC) has been identified as a brain region closely tied to cognitive control processes and crucially involved in the control of eating behaviour. This suggests the dlPFC as a target for the modulation of cognitive control processes over eating in BED. This modulation can be achieved by both, a cognitive training task and by noninvasive brain stimulation using tDCS. In studies with healthy normal-weight participants, (1) different cognitive training task enhance control over eating behaviour, (2) tDCS is an effective tool to ameliorate cognitive control processes, and (3) has beneficial effects on motivational aspects of eating behaviour, i.e. food craving. Based on this evidence, we will use a combination of a cognitive control task and tDCS to enhance cognitive control over eating in patients with BED. This is to the best of our knowledge one of the first studies to use tDCS as an intervention to enhance cognitive control over eating in patients with BED.
o Sample size: We will allocate 40 patients in the trial, i.e. 20 patients in each study arm.
o Recruitment: Patients are recruited by announcements, mails to the distributor list of the university hospital, existing databases of patients, and current patients of the university hospital. Patients are screened by a standardized checklist. In- and exclusion criteria are checked during the screening procedure and during the baseline diagnostic before randomisation.
o Standard Operating Procedures: For the recruitment, diagnostic and experimental sessions, Standard Operating Procedures are documented for the experimenter. This includes the order of clinical interviews, questionnaires and operating with the technical measurement instruments. The experimenters are regularly supervised. All adverse events will be listed and severe adverse events will be reported immediately to the PIs.
o Quality assurance plan: Randomized allocation to the stimulation condition (verum vs. sahm) and statistical analyses is done externally by the Institute of Clinical Epidemiology and Applied Biometry, University Tübingen, Germany (ICEAB). Objective technical measurement instruments are mostly used to record data.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
The participants as well as the experimenters are blinded to the treatment group by using a unique 5-digit code for each participant which activates either verum or sham stimulation. The participants and experimenters are blinded to the randomisation condition as current in the sham condition is applied for 40 seconds at the beginning of each training session and during this time, no training of the cognitive control task is done. As participants perceive typical sensations of tDCS (e.g. tingling) and tDCS electrodes are actually mounted, this is considered as a valid placebo control.
The PIs and the biostatistician from the external ICEAB who is doing the statistical analysis are blinded as well until the end of the analysis.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •BED according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
- •Legal age
- •BMI above 20 kg/m2
排除标准
- •Insufficient knowledge of German language
- •Current pregnancy or lactation period
- •Current or lifetime psychotic disorder, bipolar-I disorder, current substance dependence, suicidality
- •Past bariatric surgery
- •Severe physical disease which influence weight or eating behaviour (e.g. severe diabetes) or neurologic disease
- •Non-removable metal parts in the area of the head
- •Pacemaker
- •Neuroleptics and benzodiazepine
- •impaired vision, ametropia, eye diseases
结局指标
主要结局
Binge eating frequency
时间窗: assessed at baseline (T0) and at diagnostic post assessment four weeks after treatment (T8)
Change of the frequency of Binge eating episodes in the last 4 weeks according to the Eating Disorder Examination Interview (EDE) between baseline (T0) and diagnostic post assessment (T8). The EDE is a validated semi-structured clinical interview.
次要结局
- Body Mass Index (BMI)(at baseline (T0) and at diagnostic post assessment four weeks after treatment (T8))
- Binge eating frequency follow-up(assessed at baseline (T0) and at 3 months follow-up (T9))
- eating behaviour (TFEQ)(at baseline (T0), at the post measurement of task performance within one week after the training (T7) and at diagnostic post assessment four weeks after treatment (T8))
- Eating disorder pathology (EDE)(assessed at baseline (T0), at diagnostic post assessment four weeks after treatment (T8) and 3 months follow-up (T9))
- food craving (FCQ-S)(at baseline (T0), the six training sessions within two weeks (T1-T6) and the post measurement of task performance within one week after the training (T7))
- antisaccade task(assessed at baseline (T0), the six training sessions within two weeks (T1-T6) and the post measurement of task performance within one week after the training (T7))
- impulsive behaviours per week(at baseline (T0), the six training sessions within two weeks (T1-T6), the post measurement of task performance within one week after the training (T7) and at diagnostic post assessment four weeks after treatment (T8))
- impulsivity (UPPS)(at baseline (T0) and at diagnostic post assessment four weeks after treatment (T8))
- depressive symptoms (BDI II)(at baseline (T0) and at diagnostic post assessment four weeks after treatment (T8))
- acceptance and feasibility(from baseline (T0) throughout all measurement points until 3 months follow-up (T9))
- evaluation of the training programme(assessed at the post measurement of task performance within one week after the training (T7))
- Go/No-Go task(at baseline (T0) and at the post measurement of task performance within one week after the training (T7))
- stimulus rating(at baseline (T0) and and the post measurement of task performance within one week after the training (T7))
- well-being (WHO-5)(at baseline (T0), the post measurement of task performance within one week after the training (T7) and at diagnostic post assessment four weeks after treatment (T8))
研究者
Prof. Dr. Katrin Giel
Prof. Dr.
University Hospital Tuebingen