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

ConditionObesity

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorMasaryk University

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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/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.

Treatment groups

65 Participants

are divided into 2 treatment groups

Group A: active tDCS stimulationExperimental treatment 2 interventions

Group B: sham tDCS stimulationSham comparator 2 interventions

Trial outcomes

Primary outcomes

Cognitive impulse control measured via food-modified Go/No-Go task

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.

Time frame