Inhibitory Control Training and iTBS for Excess Weight: Behavioral and Brain Changes (InhibE).
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Overweight and Obesity, Inhibition, Psychological
In brief
People with excess weight (EW) 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 the brain level, to alterations in the activation of areas such as the dorsolateral prefrontal cortex (DLPFC) and its connectivity. The proposed intervention seeks to target these issues. Thus, the present study aims to characterize the effects of neuromodulation with intermittent theta burst transcranial magnetic stimulation (iTBS) of the DLPFC alone and in combination with inhibitory control training to produce brain, cognitive and behavioral changes, and modify altered biological parameters in people with EW. Participants will be randomly allocated to one of three groups: (1) a group that will receive active iTBS of the DLPFC combined with inhibitory control training with a food Go/No-go paradigm, (2) a group that will receive active iTBS of the DLPFC only, and (3) a control group that will receive sham iTBS. It is hypothesized that the combined intervention will obtain better results that the neuromodulation alone, and that both interventions, compared to sham iTBS, will achieve: (i) decreased body mass index, (ii) decreased craving, (iii) modified brain connectivity and activation both at rest and linked to task performance with food stimuli, (iv) improved anthropometric measures (waist circumference and waist-to-hip and waist-to-height ratios), (v) improved eating and exercise behaviors (decreased caloric intake and increased frequency and time of physical activity), (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.
Key facts
- Study ID
- NCT06668077
- Run by
- Raquel Vilar López
- People needed
- 141
- Starts
- 2024-11-30
- Expected to finish
- 2026-12-01
- Last updated by the study team
- 2025-02-14
Who can join
Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 it is running
- Mind, Brain and Behavior Research Center at University of Granada (CIMCYCUGR) — Granada, Spain (enrolling)
Full record on ClinicalTrials.gov
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