Transcranial Magnetic Stimulation and Inhibitory Control Training to Reduce Binge Eating: Brain and Behavioral Changes (BE-NEMOIC)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Binge eating symptoms
研究概览
简要总结
People with BE are characterized by high impulsivity, high levels of craving for high-calorie foods, deficits in inhibitory control, and maladaptive decision making. These characteristics are related, at brain level, to alterations in the activation of areas such as the dorsolateral prefrontal cortex (DLPFC) and ventromedial prefrontal cortex (vmPFC) among other brain areas and their connectivity. The investigators propose an intervention that seeks to target these issues. Thus, the present study aims to characterize the effects of neuromodulation with intermittent theta burst stimulation (iTBS) of the DLPFC or the vmPFC in combination with inhibitory control training to produce brain, cognitive and behavioral changes, and modify altered biological parameters in people with BE. Participants will be randomly allocated to one of three groups: 1) a group that will receive active iTBS of the DLPFC together with inhibitory control training with a food Go/NoGo paradigm, and 2) a group that will receive active iTBS of the vmPFC together with inhibitory control training with a food Go/NoGo paradigm, and 3) an active control group that will receive sham iTBS together with inhibitory control training with a food Go/NoGo paradigm. The investigators hypothesized that neuromodulation with iTBS applied to DLPFC or vmPFC will modify the dynamics of different brain circuits associated with binge eating. Neuromodulation of the DLPFC or vmPFC in combination with inhibitory control training, will be associated with: (i) decreased appraisal of unhealthy foods, (ii) reduced food craving, (iii) improved eating behavior, (iv) modified brain connectivity and activation both at rest and linked to task performance with food stimuli, (v) a decrease in the frequency and intensity of binge eating, (vi) improved emotional symptoms and emotional eating (depression, anxiety, emotional regulation, emotional eating, reward-related eating, non-homeostatic eating), (vii) improved cognitive abilities (motor and cognitive inhibition, delay of gratification, impulsivity, working memory, cognitive flexibility and decision making), (viii) changes in biological parameters associated to the interventions (plasma and microbiota), and (ix) advantages in cost-effectiveness and cost-utility based on economic evaluation analyses.
详细描述
- STARTING HYPOTHESES AND GENERAL OBJECTIVE HYPOTHESIS: Neuromodulation with intermittent theta burst stimulation (iTBS) applied to the left dorsolateral prefrontal cortex (DLPFC) or the ventromedial prefrontal cortex (vmPFC) in combination with inhibitory control training with a food Go/NoGo paradigm, will be associated with: (i) decreased appraisal of unhealthy foods, (ii) reduced food craving, (iii) improved eating behavior, (iv) modified brain connectivity and activation both at rest and linked to task performance with food stimuli, (v) a decrease in the frequency and intensity of binge eating, (vi) improved emotional symptoms and emotional eating (depression, anxiety, emotional regulation, emotional eating, reward-related eating, non-homeostatic eating), (vii) improved cognitive abilities (motor and cognitive inhibition, delay of gratification, impulsivity, working memory, cognitive flexibility and decision making), (viii) changes in biological parameters associated to the interventions (blood and microbiota), and (ix) advantages in cost-effectiveness and cost-utility based on economic evaluation analyses.
GENERAL OBJECTIVE: To determine the effects of neuromodulation with iTBS in DLPFC or vmPFC in combination with inhibitory control training to generate brain, behavioural, emotional, cognitive and biological changes in people with binge eating (BE).
1.1. Specific Aims: Objective 1: To study the differential effect of iTBS applied to the left DLPFC compared to vmPFC and sham iTBS (applied to vertex), in combination with inhibitory control training, for the treatment of people with binge eating (improvements in frequency and intensity of binge eating, craving, eating behavior, emotional symptoms and emotional eating, cognitive measures and biological parameters).
Objective 2: To characterize the effects of neuromodulation with iTBS of DLPFC or vmPFC, in combination with inhibitory control training to modify brain connectivity and activation both at rest and linked to task performance with food stimuli with functional magnetic resonance imaging (fMRI).
Objective 3: To determine the relationship of biological parameters obtained in blood, saliva, urine and faeces, as well as candidate genes, with neuropsychological variables (depression, anxiety, stress, emotional regulation, emotional eating, craving, motor and cognitive inhibition, food valuation, delay of gratification, impulsivity, working memory, flexibility and decision making) and brain neuroimaging (activation, grey and white matter volume, connectivity).
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
- Double (Participant, Outcomes Assessor)
盲法说明
The psychologists that conduct the assessments (screening, assessment sessions and follow-ups) will be blinded to the group allocation during the whole project. Further, all participants will be blind to their condition. Also, the people who perform the statistical analyses will be blind to the condition of the groups, through the coding of the interventions. Only the therapist performing the interventions will not be blind to the allocation of the participants.
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI between 20 and 39.9
- •Age between 18 and 60 years
- •Two or more binge eating episodes in the past month (assessed with the Binge Eating Scale)
- •Proficiency in the Spanish language
- •Right lateral dominance to avoid differential effects due to cortical hemispheric specialization
排除标准
- •Traumatic, digestive, metabolic or systemic disorders that affect the central nervous system, autonomic or endocrine
- •Psychopathological disorders or presence of severe symptoms in the Depression Anxiety and Stress Scale-21 (DASS-21)
- •Eeating disorders other than Binge Eating Disorder, or severe or extreme Binge Eating Disorder (8 or more binges per week)
- •Contraindication for performing functional magnetic resonance imaging (pregnancy, metal implants, etc.) or iTBS (tinnitus, dizziness, surgical interventions, diseases or drugs that affect the central nervous system, etc.).
结局指标
主要结局
Binge eating symptoms
时间窗: Pre-treatment assessment (week 2), post-treatment assessment (week 5) and follow-up (week 17)
The Binge Eating Scale (BES) is a self-administered questionnaire composed of 16 items: eight items that describe behavioral manifestations (for example, eating fast or consuming large amounts of food) and eight items on associated feelings and cognitions (for example, fear of not stopping eating). Each item has a response range from 0 to 3 points (0 = no severity of the symptom, 3 = serious problems on the symptom)
Food craving
时间窗: This will be measured in Pre-treatment assessment (week 2), post-treatment assessment (week 5) and follow-up (week 17)
The Food Craving Questionnaire Stait-reduced (FCQ-S-r) will be administered to obtain the total score, indicative of the craving state at the time of the evaluation.
次要结局
- Changes in Food decision making (neuroimaging measures)(From baseline (week 2) to the end of the treatment (week 5))
- Changes in Brain connectivity at rest (neuroimaging measures)(From baseline (week 2) to the end of the treatment (week 5))
- Changes in White matter integrity (neuroimaging measures)(From baseline (week 2) to the end of the treatment (week 5))
- Changes in Food Go/No-go Paradigm (neuroimaging measures)(From baseline (week 2) to the end of the treatment (week 5))
- Changes in eating behavior(From baseline (week 2) to the end of the treatment (week 5) and follow-up (week 17))
- Anxiety and Stress. Mean change from baseline at post-intervention(From baseline (week 2) to the end of the treatment (week 5) and follow-up (week 17))
- Depression symptoms. Mean change from baseline at post-intervention(From baseline (week 2) to the end of the treatment (week 5) and follow-up (week 17))
- Non homeostatic eating. Mean change from baseline at post-intervention(From baseline (week 2) to the end of the treatment (week 5) and follow-up (week 17))
- Reward-related eating. Mean change from baseline at post-intervention(From baseline (week 2) to the end of the treatment (week 5) and follow-up (week 17))
- Emotional eating. Mean change from baseline at post-intervention(From baseline (week 2) to the end of the treatment (week 5) and follow-up (week 17))
- Emotion Regulation Strategies. Mean change from baseline at post-intervention(From baseline (week 2) to the end of the treatment (week 5) and follow-up (week 17))
- Motor inhibition. Mean change from baseline at post-intervention(Pre-treatment assessment (week 2), post-treatment assessment (week 5) and follow-up (week 17))
- Cognitive inhibition. Mean change from baseline at post-intervention(Pre-treatment assessment (week 2), post-treatment assessment (week 5) and follow-up (week 17))
- Delay of gratification. Mean change from baseline at post-intervention(Pre-treatment assessment (week 2), post-treatment assessment (week 5) and follow-up (week 17))
- Inhibition and activation systems. Mean change from baseline at post-intervention(Pre-treatment assessment (week 2), post-treatment assessment (week 5) and follow-up (week 17))
- Self-reported impulsivity. Mean change from baseline at post-intervention(Pre-treatment assessment (week 2), post-treatment assessment (week 5) and follow-up (week 17))
- Working Memory. Mean change from baseline at post-intervention(Pre-treatment assessment (week 2), post-treatment assessment (week 5) and follow-up (week 17))
- Cognitive flexibility. Mean change from baseline at post-intervention(Pre-treatment assessment (week 2), post-treatment assessment (week 5) and follow-up (week 17))
- Decision making. Mean change from baseline at post-intervention(Pre-treatment assessment (week 2), post-treatment assessment (week 5) and follow-up (week 17))
研究者
Raquel Vilar López
Principal Investigator
Universidad de Granada