Non-invasive Brain Stimulation to Prepare the Patient for Bariatric Surgery (REBAS)
REBAS
1 other identifier
interventional
65
1 country
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable obesity
Started May 2024
Typical duration for not_applicable obesity
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2024
CompletedFirst Submitted
Initial submission to the registry
December 19, 2024
CompletedFirst Posted
Study publicly available on registry
March 13, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
March 13, 2025
March 1, 2025
2.7 years
December 19, 2024
March 11, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Baseline, 1 month and 6 months.
Secondary Outcomes (4)
Brain activation related to cognitive control assessed using a multichannel EEG system
Baseline, 1 month and 6 months.
Body bioimpedance analysis measured with the InBody 720 device
Baseline, 1 month and 6 months.
Food craving of patients assessed using Food Craving Questionnaire - Trait
Baseline, 1 month and 6 months.
Eating habits of patients assessed using the Three-Factor Eating Questionnaire
Baseline, 1 month and 6 months.
Study Arms (2)
active tDCS stimulation
EXPERIMENTALParticipants in this arm will be stimulated for 4 weeks during weekdays leading to 20 sessions of tDCS over lDLPFC.
sham tDCS stimulation
SHAM COMPARATORIn this arm, sham stimulation will be applied for 4 weeks during weekdays leading to 20 sessions of tDCS over lDLPFC.
Interventions
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)
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Masaryk Universitylead
- St. Anne´s University Hospital Brnocollaborator
Study Sites (2)
Saint Anne's University Hospital
Brno, Czechia, 60200, Czechia
Central European Institute of Technology Masaryk University
Brno, Czechia, 62500, Czechia
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Irena Rektorová, Prof.
Cetral European Institute of Technology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 19, 2024
First Posted
March 13, 2025
Study Start
May 1, 2024
Primary Completion (Estimated)
December 31, 2026
Study Completion (Estimated)
December 31, 2027
Last Updated
March 13, 2025
Record last verified: 2025-03