Actively Recruiting

Phase Not Applicable
Age: 18Years - 60Years
All Genders
Healthy Volunteers
ID06649994

Transcranial Magnetic Stimulation and Inhibitory Control Training to Reduce Binge Eating: Brain and Behavioral Changes (BE-NEMOIC)

Led by Raquel Vilar López · Updated on 2025-03-25

150

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

R

Raquel Vilar López

Lead Sponsor

J

Junta de Andalucia

Collaborating Sponsor

AI-Summary

What this Trial Is About

People with binge eating (BE) often have high impulsivity, strong cravings for high-calorie foods, poor control over their impulses, and difficulty making healthy decisions. These behaviors relate to changes in brain areas like the dorsolateral prefrontal cortex (DLPFC) and ventromedial prefrontal cortex (vmPFC). The study aims to explore how brain stimulation combined with inhibitory control training can change brain function, behavior, cognition, and biological markers in people with BE. The goal is to see if stimulating these brain areas can reduce binge eating symptoms and improve emotional and cognitive functions. Participants will be randomly assigned to one of three groups: one receiving brain stimulation (intermittent theta burst stimulation, iTBS) targeting the DLPFC, another receiving iTBS targeting the vmPFC, and a control group receiving sham stimulation at the vertex. All groups will also perform inhibitory control training using a food Go/NoGo task. The intervention lasts two weeks, with five daily sessions each week, where each session includes 3 minutes of brain stimulation followed immediately by 10 minutes of inhibitory control training. Participants will take part in an initial informative session, then pre-treatment assessments including brain imaging (fMRI), questionnaires, and biological sample collection. They will complete the intervention sessions over two weeks, followed by post-treatment assessments and a follow-up assessment three months later. Researchers will measure binge eating symptoms, food cravings, brain activity, emotional and cognitive changes, and biological markers. Monthly contact after treatment will help maintain adherence. The total program spans about five weeks with multiple evaluations.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years - 60Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • BMI between 20 and 39.9
  • Age between 18 and 60 years
  • Two or more binge eating episodes in the past month
  • Proficiency in the Spanish language
  • Right-handed dominance
Not Eligible

You will not qualify if you...

  • Traumatic, digestive, metabolic or systemic disorders affecting the central nervous system, autonomic or endocrine systems
  • Psychopathological disorders or severe symptoms on the Depression Anxiety and Stress Scale-21 (DASS-21)
  • Eating disorders other than Binge Eating Disorder or severe/extreme Binge Eating Disorder (8 or more binges per week)
  • Contraindications for MRI or iTBS, including pregnancy, metal implants, tinnitus, dizziness, surgeries, or CNS-affecting drugs or diseases

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (online questionnaire and phone/email interview)

Informative Session

Duration - 1 day

Participants attend a group briefing session to receive information about the study and provide informed consent.

1 group session (online via GoogleMeet)

Pre-treatment Assessment

Duration - 1 week

Participants complete questionnaires, neuropsychological tests, biological sample collection, and fMRI to assess baseline measures.

2 sessions (1 fMRI and 1 questionnaire session)

Treatment

Duration - 2 weeks

Participants receive 10 daily individual intervention sessions over 2 weeks, each consisting of 3 minutes of neuromodulation (iTBS) followed immediately by 10 minutes of inhibitory control training.

10 individual daily sessions over 2 weeks

Post-treatment Assessment

Duration - 1 week

Participants repeat questionnaires, neuropsychological tests, biological sample collection, and fMRI to evaluate treatment effects.

2 sessions (1 fMRI and 1 questionnaire session)

Follow-up

Duration - 1 day

Participants complete follow-up assessments including questionnaires, biological sample collection, and interviews to evaluate long-term effects 3 months after treatment.

1 session (assessment and sample collection)

Trial Site Locations

Total: 1 location

1

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

Granada, Spain, 18071

Actively Recruiting

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Research Team

R

Raquel Vilar-López, Ph.D.

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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Published Research Related To This Trial

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.

Jennifer Barone, Massimiliamo Oliveri, Rosario Emanuele Bonaventura...

https://pubmed.ncbi.nlm.nih.gov/37007674

Human dorsolateral prefrontal cortex is involved in visual search for conjunctions but not features: a theta TMS study.

Roger Kalla, Neil G Muggleton, Alan Cowey...

https://pubmed.ncbi.nlm.nih.gov/19269631

App-based food-specific inhibitory control training as an adjunct to treatment as usual in binge-type eating disorders: A feasibility trial.

Johanna Louise Keeler, Rayane Chami, Valentina Cardi...

https://pubmed.ncbi.nlm.nih.gov/34728250

Safety and recommendations for TMS use in healthy subjects and patient populations, with updates on training, ethical and regulatory issues: Expert Guidelines.

Simone Rossi, Andrea Antal, Sven Bestmann...

https://pubmed.ncbi.nlm.nih.gov/33243615

Safety, ethical considerations, and application guidelines for the use of transcranial magnetic stimulation in clinical practice and research.

Simone Rossi, Mark Hallett, Paolo M Rossini...

https://pubmed.ncbi.nlm.nih.gov/19833552

The Binge Eating Scale: Structural Equation Competitive Models, Invariance Measurement Between Sexes, and Relationships With Food Addiction, Impulsivity, Binge Drinking, and Body Mass Index.

Tamara Escrivá-Martínez, Laura Galiana, Marta Rodríguez-Arias...

https://pubmed.ncbi.nlm.nih.gov/30967808