Actively Recruiting
Inhibitory Control Training and Theta Burst Transcranial Magnetic Stimulation (iTBS) for Treating People With Excess Weight: Behavioral and Brain Changes (InhibE).
Led by Raquel Vilar López · Updated on 2025-02-14
141
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
R
Raquel Vilar López
Lead Sponsor
G
Government of Spain
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying people with excess weight who often experience high impulsivity, strong cravings for high-calorie foods, difficulty controlling impulses, and poor decision-making. These issues are linked to changes in brain areas like the dorsolateral prefrontal cortex (DLPFC). This trial aims to explore how neuromodulation using intermittent theta burst transcranial magnetic stimulation (iTBS) of the DLPFC, alone or combined with inhibitory control training, affects brain function, behavior, and biological markers in people with excess weight. Participants will be randomly assigned to one of three groups: one receiving active iTBS of the left DLPFC combined with inhibitory control training using a food Go/No-go task on a smartphone app; one receiving active iTBS of the left DLPFC alone; and a control group receiving sham iTBS of the vertex. The intervention lasts two weeks with five daily sessions each week. Each session includes 3 minutes of iTBS and, for the combined group, 10 minutes of cognitive training immediately after stimulation. Before this, all groups receive information sessions and guidance on diet and exercise. Participants undergo assessments at three times: before treatment, after treatment, and at a three-month follow-up. These include questionnaires, brain imaging with fMRI, biological sample collection (blood, saliva, urine, feces), and measurements of body size. Researchers measure changes in body mass index, brain activation during tasks, food cravings, eating and exercise behaviors, emotional and cognitive function, and biological markers. The study also evaluates the cost-effectiveness of these interventions and monitors safety throughout the study period, which spans six weeks from initial sessions to follow-up.
CONDITIONS
Brief Title
Inhibitory Control Training and iTBS for Excess Weight: Behavioral and Brain Changes (InhibE).
Who Can Participate
Eligibility Criteria
You may qualify if you...
- BMI between 25 and 39.9
- Age between 18 and 60 years
- Proficiency in the Spanish language
- Right lateral dominance (right-handedness) to avoid differential effects due to brain hemispheric specialization
You will not qualify if you...
- Traumatic, digestive, metabolic, or systemic disorders affecting the central nervous system, autonomic system, or endocrine system
- Severe psychopathological disorders, suicidal ideation, or treatment for depression
- Eating disorders
- Contraindications for fMRI (e.g., pregnancy, metal implants) or iTBS (e.g., tinnitus, dizziness, surgeries, diseases, or drugs affecting the central nervous system)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 2 to 3 weeks
Participants attend an information session about the study and provide informed consent. They complete pre-treatment assessments including questionnaires, fMRI scans, biological sample collection, and anthropometric measures. Participants also receive individualized diet and physical exercise guidance.
1 group informative session and 4 individual pre-treatment sessions
Duration - 2 weeks
Participants undergo 2 weeks of intervention with 5 individual sessions per week. Depending on the group, this includes 3 minutes of iTBS neuromodulation followed immediately by 10 minutes of inhibitory control training or iTBS alone. Each session lasts 10 to 20 minutes.
10 individual sessions over 2 weeks (5 sessions per week)
Duration - 1 week
Participants complete post-treatment assessments including questionnaires, fMRI scans, biological sample collection, and anthropometric measures to evaluate the effects of the intervention.
3 assessment sessions
Duration - 1 day
Three months after completing the intervention, participants complete follow-up assessments including questionnaires, biological sample collection, and anthropometric measures to monitor lasting effects.
1 follow-up visit
Trial Site Locations
Total: 1 location
1
Mind, Brain and Behavior Research Center at University of Granada (CIMCYCUGR)
Granada, Spain
Actively Recruiting
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
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here