Transcranial Magnetic Stimulation and Inhibitory Control Training to Reduce Binge Eating: Brain and Behavioral Changes

NCT06649994 | Recruiting

• 1 other identifier: ProyExcel_00776
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Binge Eating; Inhibition, Psychological

Keywords

binge eating; rTMS; inhibitory control; training

Outcome Measures

Primary Outcomes (2)

• Binge eating symptoms

  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)

  Pre-treatment assessment (week 2), post-treatment assessment (week 5) and follow-up (week 17)

• Food craving

  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.

  This will be measured in Pre-treatment assessment (week 2), post-treatment assessment (week 5) and follow-up (week 17)

Secondary Outcomes (19)

• 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)

Other Outcomes (24)

• Descriptive measures

  Pre-treatment assessment (week 2)

• Depression Symptoms. Screening

  Pre-treatment assessment (week 2)

• Anxiety Symptoms. Screening

  Pre-treatment assessment (week 2)

Study Arms (3)

Active iTBS of the DLPFC

EXPERIMENTAL

The experimental group will: i) receive an informative session; ii) 2 sessions of pre-treatment assessment (one with fMRI and one with questionnaires); iii) participate in 10 daily individual intervention sessions that consist of iTBS of the left dlPFC followed immediately inhibitory control training, that will last about 10-20 minutes each; iv) 2 sessions of post-treatment assessment (one with fMRI and one with questionnaires); v) one follow-up assessment session three months after completing the intervention

Device: Active iTBS of the DLPFC; Behavioral: Computerized inhibitory control training

Active iTBS of the vmPFC

EXPERIMENTAL

The experimental group will: i) receive an informative session; ii) 2 sessions of pre-treatment assessment (one with fMRI and one with questionnaires); iii) participate in 10 daily individual intervention sessions that consist of iTBS of the vmPFC followed immediately by inhibitory control training, that will last about 10-20 minutes each; iv) 2 sessions of post-treatment assessment (one with fMRI and one with questionnaires); v) one follow-up assessment session three months after completing the intervention

Device: Active iTBS of the vmPFC; Behavioral: Computerized inhibitory control training

Active Control

PLACEBO COMPARATOR

The active control group will: i) receive an informative session; ii) 2 sessions of pre-treatment assessment (one with fMRI and one with questionnaires); iii) participate in 10 daily individual intervention sessions that consist of iTBS of the vertex (sham) followed immediately by inhibitory control training, that will last about 10-20 minutes each; iv) 2 sessions of post-treatment assessment (one with fMRI and one with questionnaires); v) one follow-up assessment session three months after completing the intervention

Device: iTBS of the vertex (sham); Behavioral: Computerized inhibitory control training

Interventions

Active iTBS of the DLPFC DEVICE

Participants will receive a 3 minutes intermittent Theta Burst Stimulation of the DLPCF of the left hemisphere while not performing any other task

Active iTBS of the DLPFC

Active iTBS of the vmPFC DEVICE

Participants will receive a 3 minutes active intermittent Theta Burst Stimulation of the vmPFC while not performing any other task

Active iTBS of the vmPFC

iTBS of the vertex (sham) DEVICE

Participants will receive a 3 minutes active intermittent Theta Burst Stimulation of the vertex while not performing any other task

Active Control

Computerized inhibitory control training BEHAVIORAL

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

Also known as: FoodT

Active Control; Active iTBS of the DLPFC; Active iTBS of the vmPFC

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.).

Sponsors & Collaborators

• Raquel Vilar López: lead
• Junta de Andalucia: collaborator

Study Sites (1)

Mind, Brain and Behavior Research Center at University of Granada (CIMCYC-UGR)

Granada, 18071, Spain

RECRUITING

Related Publications (29)

• Barone J, Oliveri M, Bonaventura RE, Mangano GR. Reduction of drive for thinness and body dissatisfaction in people with self-reported dysregulated eating behaviors after intermittent theta burst stimulation (iTBS) of the left dorsolateral prefrontal cortex. Front Hum Neurosci. 2023 Mar 17;17:1108869. doi: 10.3389/fnhum.2023.1108869. eCollection 2023.

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  BACKGROUND

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Related Links

• Web of the project

MeSH Terms

Conditions

Bulimia; Inhibition, Psychological

Condition Hierarchy (Ancestors)

Hyperphagia; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Raquel Vilar-López, Ph.D

  Universidad de Granada

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raquel Vilar-López, Ph.D.

CONTACT

+34699407282; rvilar@ugr.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel group randomized controlled trial

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: October 21, 2024
• Study Start: April 29, 2024
• Primary Completion (Estimated): December 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 25, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data will be available beginning 3 months and ending 5 years following article publication.
• Access Criteria: Investigators whose proposed use of the data has been approved by an independent review committee and who provide a methodologically sound proposal. Proposals should be directed to rvilar@ugr.es

Locations

ES (1)