Clinical trial
Inhibitory Control Training and iTBS for Excess Weight: Behavioral and Brain Changes (InhibE).
Recruiting now · Not applicable · 1 countries · Registry ID NCT06668077
What this study is about
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.
Basic eligibility
Full registry criteria
Treatments and study arms
iTBS of the left DLPFC
Participants will receive a 3 minutes active theta burst transcranial magnetic stimulation (iTBS) of the DLPFC of the left hemisphere while not performing any other task
iTBS of the vertex
Participants will receive a 3 minutes active theta burst transcranial magnetic stimulation (iTBS) of the vertex while not performing any other task
Inhibitory control training
Computerized cognitive training. Participants will perform the task of the FoodT app for 10 minutes during two weeks (taking advantage of time of maximum brain potentiation after the iTBS, Rossi et al., 2009). Images of food and non-food appear on the left, right or centre of the smart phone screen and participants must touch it (or not, depending on the cue) with their index finger as quickly as possible. Participants earn points for correct tap responses and lose points for incorrect tap responses. If the image has a green border around it, participants must tap the image and win 1 point. But if the image has a red border around it, participants must inhibit the tapping response, otherwise 1 point will be lost. Participants must respond as quickly and accurately as possible. Pictures of healthy and unhealthy foods are always paired with the Go and the No-Go signal, respectively. Non-food images are paired 50% of the time with the Go and the No-Go signal
Primary outcomes
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).
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 b…
Study locations
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