RECRUITINGINTERVENTIONAL

Inhibitory Control Training and iTBS for Excess Weight: Behavioral and Brain Changes (InhibE).

Inhibitory Control Training and Theta Burst Transcranial Magnetic Stimulation (iTBS) for Treating People With Excess Weight: Behavioral and Brain Changes (InhibE).

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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.) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * 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 Exclusion Criteria: * 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.)

Treatments Being Tested

DEVICE

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

DEVICE

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

BEHAVIORAL

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

Locations (1)

Mind, Brain and Behavior Research Center at University of Granada (CIMCYCUGR)

Granada, Spain