Training to improve brain control and reduce excess weight
Inhibitory Control Training and Theta Burst Transcranial Magnetic Stimulation (iTBS) for Treating People With Excess Weight: Behavioral and Brain Changes (InhibE).
This study is testing whether a new brain training method combined with a special type of brain stimulation can help people with excess weight make healthier choices and improve their overall well-being.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 141 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | All |
| Sponsor | Universidad de Granada Academic / other |
| Locations | 1 site (Granada) |
| Trial ID | NCT06668077 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of intermittent theta burst transcranial magnetic stimulation (iTBS) on the dorsolateral prefrontal cortex (DLPFC) combined with inhibitory control training to address issues related to excess weight. Participants will be randomly assigned to receive either active iTBS with training, active iTBS alone, or a control condition. The study aims to evaluate changes in body mass index (BMI), cravings, cognitive functions, and emotional well-being, as well as alterations in brain connectivity and activation. By targeting impulsivity and decision-making deficits, the intervention seeks to promote healthier behaviors and improve overall health outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 to 60 with a BMI between 25 and 39.9 who are proficient in Spanish.
Not a fit: Patients with severe psychological disorders, eating disorders, or contraindications for iTBS or fMRI will not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could lead to significant reductions in weight and improvements in cognitive and emotional health for individuals struggling with excess weight.
How similar studies have performed: While the combination of iTBS and cognitive training is a novel approach, similar studies have shown promise in using neuromodulation techniques for behavioral and cognitive improvements.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * BMI between 25 and 39.9 * Age between 18 and 60 years * 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 * Severe psychopathological disorders and suicidal ideation or treatment for depression * Eating disorders * Contraindication for performing fMRI (pregnancy, metal implants, etc.) or iTBS (tinnitus, dizziness, surgical interventions, diseases or drugs that affect the CNS, etc.)
Where this trial is running
Granada
- Mind, Brain and Behavior Research Center at University of Granada (CIMCYCUGR) — 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.