Inhibitory Control Training and Theta Burst Transcranial Magnetic Stimulation (iTBS) for Treating People With Excess Weight: Behavioral and Brain Changes (InhibE).
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 141
- 试验地点
- 1
- 主要终点
- Body Mass Index (BMI)
研究概览
简要总结
People with excess weight (EW) 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 the brain level, to alterations in the activation of areas such as the dorsolateral prefrontal cortex (DLPFC) and its connectivity. The proposed intervention seeks to target these issues. Thus, the present study aims to characterize the effects of neuromodulation with intermittent theta burst transcranial magnetic stimulation (iTBS) of the DLPFC alone and in combination with inhibitory control training to produce brain, cognitive and behavioral changes, and modify altered biological parameters in people with EW. Participants will be randomly allocated to one of three groups: (1) a group that will receive active iTBS of the DLPFC combined with inhibitory control training with a food Go/No-go paradigm, (2) a group that will receive active iTBS of the DLPFC only, and (3) a control group that will receive sham iTBS. It is hypothesized that the combined intervention will obtain better results that the neuromodulation alone, and that both interventions, compared to sham iTBS, will achieve: (i) decreased body mass index, (ii) decreased craving, (iii) modified brain connectivity and activation both at rest and linked to task performance with food stimuli, (iv) improved anthropometric measures (waist circumference and waist-to-hip and waist-to-height ratios), (v) improved eating and exercise behaviors (decreased caloric intake and increased frequency and time of physical activity), (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:
HYPOTHESIS: Neuromodulation with iTBS applied to the left DLPFC in combination with inhibitory control training with a food Go/No-go paradigm will be associated with decreased (i) BMI, and (ii) craving; (iii) modified brain connectivity and activation both at rest and linked to task performance with food stimuli; improved (iv) anthropometric measures (waist circumference and waist-to-hip and waist-to-height ratios), (v) eating and exercise behaviors (caloric intake increased frequency and time of physical activity), (vi) emotional symptoms and emotional eating (depression, anxiety, emotional regulation, emotional eating, reward-related eating, non-homeostatic eating), (vii) cognitive abilities (motor and cognitive inhibition, delay of gratification, impulsivity, working memory, cognitive flexibility and decision making); (viii) changes in biological parameters (plasma 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 alone and in combination with inhibitory control training to generate brain, behavioural, emotional, cognitive and biological changes in people with EW.
1.1. Specific Aims: Objective 1: To determine the effectiveness of iTBS of the DLPFC as an add-on to the treatment as usual (TAU: diet and exercise) for the treatment of people with excess weight (improvements in BMI, craving, anthropometric measures, food and exercise behaviours, emotional symptoms and emotional eating, cognitive measures and biological parameters).
Objective 2: To study the effectiveness of combining iTBS and inhibitory control training compared to iTBS alone (both as an add-on to TAU), for the treatment of EW (using the same parameters before) Objective 3: To characterize the effects of neuromodulation with iTBS of DLPFC alone and 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).
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 25 and 39.9
- •Age between 18 and 60 years
- •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
- •Severe psychopathological disorders and suicidal ideation or treatment for depression
- •Eating disorders
- •Contraindication for performing fMRI (pregnancy, metal implants, etc.) or iTBS (tinnitus, dizziness, surgical interventions, diseases or drugs that affect the CNS, etc.)
研究组 & 干预措施
Combined intervention
Experimental: Active iTBS of the DLPFC combined with inhibitory control training. An experimental group will receive: i) an informative session; ii) 4 pre treatment sessions (one assessment session with questionnaires, one with fMRI and one with biological samples. Also, a counselling session on diet and on physical exercise); iii) participate in 2 weekly individual intervention sessions that consist of iTBS of the left DLPFC (10 min) followed immediately by inhibitory control training for 10 minutes; iv) 3 sessions of post treatment assessment (one with questionnaires, one with fMRI and one with biological samples); v) 2 follow-up assessment sessions (3 months after completing the intervention) to repeat questionnaires and biological samples
干预措施: iTBS of the left DLPFC (Device)
Combined intervention
Experimental: Active iTBS of the DLPFC combined with inhibitory control training. An experimental group will receive: i) an informative session; ii) 4 pre treatment sessions (one assessment session with questionnaires, one with fMRI and one with biological samples. Also, a counselling session on diet and on physical exercise); iii) participate in 2 weekly individual intervention sessions that consist of iTBS of the left DLPFC (10 min) followed immediately by inhibitory control training for 10 minutes; iv) 3 sessions of post treatment assessment (one with questionnaires, one with fMRI and one with biological samples); v) 2 follow-up assessment sessions (3 months after completing the intervention) to repeat questionnaires and biological samples
干预措施: Inhibitory control training (Behavioral)
Active iTBS
Experimental: Active iTBS of the DLPFC only. An experimental group will receive: i) an informative session; ii) 4 pre treatment sessions (one assessment session with questionnaires, one with fMRI and one with biological samples. Also, a counselling session on diet and on physical exercise); iii) participate in 2 weekly individual intervention sessions that consist of iTBS of the left DLPFC that will last about 10 minutes each; iv) 3 sessions of post treatment assessment (one with questionnaires, one with fMRI and one with biological samples); v) 2 follow-up assessment sessions (3 months after completing the intervention) to repeat questionnaires and biological samples
干预措施: iTBS of the left DLPFC (Device)
Sham iTBS
Control: iTBS of the vertex (sham). The control group will receive: i) an informative session; ii) 4 pre treatment sessions (one assessment session with questionnaires, one with fMRI and one with biological samples. Also, a counselling session on diet and on physical exercise); iii) participate in 2 weekly individual intervention sessions that consist of iTBS of the vertex that will last about 10 minutes each; iv) 3 sessions of post treatment assessment (one with questionnaires, one with fMRI and one with biological samples); v) 2 follow-up assessment sessions (3 months after completing the intervention) to repeat questionnaires and biological samples
干预措施: iTBS of the vertex (Device)
结局指标
主要结局
Body Mass Index (BMI)
时间窗: Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18)
Change in BMI: Weight and height will be combined to report BMI in kg/m\^2. Weight will be obtained in kilograms with a digital scale (TANITA Corporation of America) and height in meters with a measuring rod (SECA Tape Measure 206).
Changes in brain activation during a inhibitory control task (neuroimaging measures)
时间窗: Pre-treatment assessment (week 2) and post-treatment assessment (week 6)
Food Go/No-go task (Based on the FoodTrainer App; Lawrence et al., 2015): Pictures appear and afterwards a green (Go signal) or red (No-Go signal) circle appears around them. Participants are instructed to score points by answering with a knob if the image is surrounded by a green circle, but not to press when the image is surrounded by a red circle. The presentation of the images is the same as in the FoodTrainer application: 50% of the images are food, with 100% of the healthy ones being presented under the 'Go' condition and 100% of the unhealthy ones under the 'No-Go' condition. The remaining 50% are non-food images, with 50-50% paired with 'Go' and 'No-Go' cues. In addition, participants can choose which categories of unhealthy foods they want to train. Brain activation to Go vs. No-Go stimuli and food vs. non-food stimuli will be compared. The task will be analysed to assess the brain activity associated with the task, using a psychophysiological interaction analysis(PPI).
次要结局
- Exercise adherence. Mean change from baseline at post-intervention(Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18))
- Changes in White matter integrity (neuroimaging measures)(Pre-treatment assessment (week 2) and post-treatment assessment (week 6))
- Changes in Food decision-making (neuroimaging measures)(Pre-treatment assessment (week 2) and post-treatment assessment (week 6))
- Changes in Brain connectivity at rest (neuroimaging measures)(Pre-treatment assessment (week 2) and post-treatment assessment (week 6))
- Waist-to-height ratio (WHtR). Mean change from baseline at post-intervention(Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18))
- Food Craving. Mean change from baseline at post-intervention(Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18))
- Eating behaviour. Mean change from baseline at post-intervention(Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18))
- Physical activity behaviour. Mean change from baseline at post-intervention(Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18))
- Adherence to diet. Mean change from baseline at post-intervention(Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18))
- Depression symptoms. Mean change from baseline at post-intervention(Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18))
- Anxiety and Stress. Mean change from baseline at post-intervention(Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18))
- Reward-related eating. Mean change from baseline at post-intervention(Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18))
- Non homeostatic eating. Mean change from baseline at post-intervention(Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18))
- Emotional eating. Mean change from baseline at post-intervention(Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18))
- Emotion Regulation Strategies. Mean change from baseline at post-intervention(Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18))
- Motor inhibition. Mean change from baseline at post-intervention(Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18))
- Cognitive inhibition. Mean change from baseline at post-intervention(Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18))
- Delay of gratification. Mean change from baseline at post-intervention(Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18))
- Inhibition and activation systems. Mean change from baseline at post-intervention(Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18))
- Self-reported impulsivity. Mean change from baseline at post-intervention(Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18))
- Working Memory. Mean change from baseline at post-intervention(Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18))
- Cognitive flexibility. Mean change from baseline at post-intervention(Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18))
- Decision making. Mean change from baseline at post-intervention(Pre-treatment assessment (week 2), post-treatment assessment (week 6) and follow-up (week 18))
研究者
Raquel Vilar López
Principal Investigator
Universidad de Granada