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

March 11, 2025 updated by: Masaryk University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Obesity, defined as a body mass index (BMI) above 30 kg/m² or through other body composition measurements like waist circumference or body fat percentage, is a major risk factor for cardiovascular, neurological, and oncological diseases. It is one of the leading causes of mortality in both men and women. The prevalence of obesity is increasing globally, particularly among younger populations, surpassing undernutrition and posing significant health and socio-economic challenges.

Excess fat accumulation, a hallmark of obesity, impacts the structure and function of nearly all organ systems. This occurs through both physical mechanisms, such as fat deposition around organs, and functional mechanisms, including chronic low-grade inflammation, insulin resistance, dyslipidemia, and altered hormone production and regulation by adipose tissue.

While various therapies have been developed to address the negative effects of obesity on body structure and function, early interventions like lifestyle changes and pharmacotherapy have shown only mild and often temporary weight reduction. These approaches frequently lead to cyclical weight changes, which have been linked to increased cardiovascular risk.

Bariatric surgery has emerged as the most effective treatment for severe obesity, delivering significant and long-lasting weight reduction compared to lifestyle modifications. While lifestyle interventions typically achieve a weight loss of 5-10%, bariatric surgery can result in reductions of 15-20%. However, a notable challenge is the risk of failure, primarily due to noncompliant eating behaviors after surgery. Approximately 40% of individuals with extreme obesity are at high risk of experiencing suboptimal outcomes following bariatric surgery.

To address this issue, our project aims to improve the sustainability of bariatric surgery outcomes by incorporating neuromodulation before the procedure. Specifically, the investigators propose using transcranial direct current stimulation (tDCS) to enhance prefrontal inhibitory control by targeting the left dorsolateral prefrontal cortex (lDLPFC). This home-based, non-invasive brain stimulation method seeks to improve behavioral regulation, potentially reducing the likelihood of postoperative complications related to eating habits.

Additionally, researchers aim to identify neural, cognitive, and behavioral predictors of successful bariatric surgery outcomes. By examining these factors, investigators plan to optimize treatment strategies, ensuring more effective and sustainable results for individuals undergoing bariatric surgery.

Study Type

Interventional

Enrollment (Estimated)

65

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Czech Republic
    • Czechia
      • Brno, Czechia, Czech Republic, 60200
        • Recruiting
        • Saint Anne's University Hospital
        • Contact:
      • Brno, Czechia, Czech Republic, 62500

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: active tDCS stimulation
Participants in this arm will be stimulated for 4 weeks during weekdays leading to 20 sessions of tDCS over lDLPFC.
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)
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.
Sham Comparator: sham tDCS stimulation
In this arm, sham stimulation will be applied for 4 weeks during weekdays leading to 20 sessions of tDCS over lDLPFC.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognitive impulse control measured via food-modified Go/No-Go task
Time Frame: Baseline, 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.
Baseline, 1 month and 6 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Brain activation related to cognitive control assessed using a multichannel EEG system
Time Frame: Baseline, 1 month and 6 months.
The investigators will evaluate brain activity in response to food-modified Go/No-Go stimuli and during rest, using Time-Frequency Analysis, focusing on theta and beta power.
Baseline, 1 month and 6 months.
Body bioimpedance analysis measured with the InBody 720 device
Time Frame: Baseline, 1 month and 6 months.
Patients, wearing light clothing and standing barefoot with their legs slightly apart, will hold the device's sensors. Within seconds, the device calculates parameters such as total body water, fat mass, muscle mass, and segmental composition.
Baseline, 1 month and 6 months.
Food craving of patients assessed using Food Craving Questionnaire - Trait
Time Frame: Baseline, 1 month and 6 months.
The questionnaire has 21 items with a response scale 1-6, higher score means stronger cravings.
Baseline, 1 month and 6 months.
Eating habits of patients assessed using the Three-Factor Eating Questionnaire
Time Frame: Baseline, 1 month and 6 months.
The Questionnaire has 51 items in total, 36 items ask for true/false judgment, and 15 items are scored on a 4-point Likert-type scale, each item scores either 0 or 1 point, the minimum score for factors Cognitive Restraint, Disinhibition, and Hunger is 0-0-0, the possible maximum score is 21-16-14.
Baseline, 1 month and 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Masaryk University

Collaborators

St. Anne´s University Hospital Brno

Investigators

  • Principal Investigator: Irena Rektorová, Prof., Cetral European Institute of Technology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

December 19, 2024

First Submitted That Met QC Criteria

March 11, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 11, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NW24-04-00392

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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