Clinical trial

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

Recruiting now · Not applicable · 1 countries · Registry ID NCT06874309

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersNot accepted

ConditionObesity

Full registry criteria

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 and study arms

home-based tDCS stimulation

Device

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)

home-based tDCS stimulation - sham

Device

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.

Bariatric surgery

Procedure

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.

Primary outcomes

Cognitive impulse control measured via food-modified Go/No-Go taskBaseline, 1 month and 6 months.

The cognitive task is used to assess response inhibition, particularly in the context of food-related stimuli. It is a variation of the standard Go/No-Go task, where participants must respond quickly to "Go" stimuli (low-calorie item) while withholding responses to "No-Go" stimuli (high-calorie item). Researchers analyze reaction times, accuracy, and commission errors (responses to No-Go stimuli) to evaluate impulse control.

Study locations

2 locations were listed when this page was built. The first 40 are shown.

Central European Institute of Technology Masaryk University🇨🇿 Brno, Czechia, Czechia

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Petra Holštajn ZemánkováContact

Email · Call +420776722029

Sylvie KropáčováContact

Petra Holštajn Zemánková, Dr.Sub Investigator

Saint Anne's University Hospital🇨🇿 Brno, Czechia, Czechia

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Jana JarešováContact

Email · Call +420705 629 051