Using brain stimulation and training to help reduce binge eating
Transcranial Magnetic Stimulation and Inhibitory Control Training to Reduce Binge Eating: Brain and Behavioral Changes (BE-NEMOIC)
This study is testing whether a combination of brain stimulation and training can help people with binge eating disorder control their cravings and improve their eating habits.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Universidad de Granada Academic / other |
| Locations | 1 site (Granada) |
| Trial ID | NCT06649994 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of intermittent theta burst stimulation (iTBS) on the dorsolateral prefrontal cortex (DLPFC) and ventromedial prefrontal cortex (vmPFC) in combination with inhibitory control training to address binge eating behaviors. Participants will be randomly assigned to receive either active brain stimulation or a sham treatment while undergoing computerized training designed to improve their ability to control food cravings. The study aims to assess changes in brain activity, eating behaviors, emotional regulation, and cognitive functions, as well as biological parameters related to the interventions. By targeting impulsivity and craving, the study seeks to provide a comprehensive approach to treating binge eating disorder.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 60 with a BMI between 20 and 39.9 who experience two or more binge eating episodes per month.
Not a fit: Patients with severe binge eating disorder, other eating disorders, or significant psychological disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly reduce binge eating episodes and improve overall emotional and cognitive functioning in affected individuals.
How similar studies have performed: While the approach of combining brain stimulation with behavioral training is innovative, similar studies have shown promising results in addressing impulsivity and craving in various psychological conditions.
Eligibility criteria
Show full inclusion / exclusion 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.).
Where this trial is running
Granada
- Mind, Brain and Behavior Research Center at University of Granada (CIMCYC-UGR) — Granada, Spain (Recruiting)
Study contacts
- Principal investigator: Raquel Vilar-López, Ph.D — Universidad de Granada
- Study coordinator: Raquel Vilar-López, Ph.D.
- Email: rvilar@ugr.es
- Phone: +34699407282
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.