NCT06649994 Transcranial Magnetic Stimulation and Inhibitory Control Training to Reduce Binge Eating: Brain and Behavioral Changes
| NCT ID | NCT06649994 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Raquel Vilar López |
| Condition | Binge Eating |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2024-04-29 |
| Primary Completion | 2026-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 150 participants in total. It began in 2024-04-29 with a primary completion date of 2026-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * 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.).
Contact & Investigator
Raquel Vilar-López, Ph.D
PRINCIPAL INVESTIGATOR
Universidad de Granada
Frequently Asked Questions
Who can join the NCT06649994 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Binge Eating. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06649994 currently recruiting?
Yes, NCT06649994 is actively recruiting participants. Contact the research team at rvilar@ugr.es for enrollment information.
Where is the NCT06649994 trial being conducted?
This trial is being conducted at Granada, Spain.
Who is sponsoring the NCT06649994 clinical trial?
NCT06649994 is sponsored by Raquel Vilar López. The principal investigator is Raquel Vilar-López, Ph.D at Universidad de Granada. The trial plans to enroll 150 participants.