Transcranial Magnetic Stimulation and Inhibitory Control Training to Reduce Binge Eating: Brain and Behavioral Changes
Transcranial Magnetic Stimulation and Inhibitory Control Training to Reduce Binge Eating: Brain and Behavioral Changes (BE-NEMOIC)
Raquel Vilar López
150 participants
Apr 29, 2024
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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
Exclusion Criteria4
- 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.).
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Participants will receive a 3 minutes intermittent Theta Burst Stimulation of the DLPCF of the left hemisphere while not performing any other task
Participants will receive a 3 minutes active intermittent Theta Burst Stimulation of the vmPFC while not performing any other task
Participants will receive a 3 minutes active intermittent Theta Burst Stimulation of the vertex while not performing any other task
Participants will perform the task of the FoodT app for 10 minutes immediately after iTBS (taking advantage of time of maximum brain potentiation, Rossi et al., 2009). This task pairs high-calorie meals with the no-go cue. Images appear on the left, right or center of the smartphone screen and they 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, you must tap the image and win 1 point. But if the image has a red border around it, you must inhibit the tapping response or you will lose 1 point. Participants must respond as quickly and accurately as possible and improve reaction time. 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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06649994