RECRUITINGINTERVENTIONAL

Non-invasive Brain Stimulation to Prepare the Patient for Bariatric Surgery (REBAS)

Non-invasive Brain Stimulation to Prepare the Patient for Bariatric Surgery

About This Trial

Obesity is a chronic metabolic condition characterized by excessive accumulation of body fat, which triggers physiological mechanisms that increase the risk of a wide range of health problems. The most effective treatment for severe obesity is metabolic-bariatric surgery, which can lead to a 15-20% weight reduction, significantly lowering the risks of illness and death. However, the success of this surgery can be threatened by poor eating habits after the procedure. The main goal of this study is to enhance the long-term effectiveness of bariatric surgery by combining it with non-invasive brain stimulation (tDCS) targeting inhibitory centers before the operation. Additionally, the investigators aim to comprehensively monitor patients before and after surgery, focusing on investigating changes in brain function associated with the achieved weight loss.

Who May Be Eligible (Plain English)

Who May Qualify: - Subjects with severe or morbid obesity (determined by BMI \> 35 or 40 kg/m2, respectively) eligible for BS treatment in compliance with the current guidelines - Subjects who meet reduced control over eating behavior (disinhibition) criteria in the Eating Habits Questionnaire Who Should NOT Join This Trial: - Subjects unable to provide willing to sign a consent form and those unable to understand and cooperate with study-related procedures (based on the physician's discretion) - Subjects with a personal history of ischemic heart disease, myocardial infarction, stroke, heart failure, and atrial fibrillation - Subjects who have already undergone BS treatment in the past - Pregnant subjects or subjects that plan on becoming pregnant during the study. - Subjects deemed unsuitable for the study based on expert evaluation (e.g., by a physician or neuropsychologist) will be excluded. - Subjects with dreadlocks (problematic for the EEG) Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

Inclusion Criteria: * Subjects with severe or morbid obesity (determined by BMI \> 35 or 40 kg/m2, respectively) eligible for BS treatment in compliance with the current guidelines * Subjects who meet reduced control over eating behavior (disinhibition) criteria in the Eating Habits Questionnaire Exclusion Criteria: * Subjects unable to provide informed consent and those unable to understand and cooperate with study-related procedures (based on the physician's discretion) * Subjects with a personal history of ischemic heart disease, myocardial infarction, stroke, heart failure, and atrial fibrillation * Subjects who have already undergone BS treatment in the past * Pregnant subjects or subjects that plan on becoming pregnant during the study. * Subjects deemed unsuitable for the study based on expert evaluation (e.g., by a physician or neuropsychologist) will be excluded. * Subjects with dreadlocks (problematic for the EEG)

Treatments Being Tested

DEVICE

home-based tDCS stimulation

stimulation parameters: 20 sessions of tDCS over lDLPFC (anode over F3, based on the 10:20 system, and cathode over the right supraorbital area), 2 mA intensity, 20 min duration (30 s fade in/fade out)

DEVICE

home-based tDCS stimulation - sham

20 sessions of tDCS over lDLPFC (anode over F3, based on the 10:20 system, and cathode over the right supraorbital area), the electric current will flow for only 15 s, with similar fade in/fade out, at the beginning and at the end of 20 min, to mimic the subjective sensations that occur during active tDCS.

PROCEDURE

Bariatric surgery

The operation itself is not a study-related procedure and thus the indicated patients would undergo the surgery regardless of their participation in this study. The operating surgeons will perform either Roux-en-Y or gastric sleeve resection.

Locations (2)

Saint Anne's University Hospital

Brno, Czechia, Czechia

Central European Institute of Technology Masaryk University

Brno, Czechia, Czechia