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RECRUITING
NCT06874309
NA

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

Sponsor: Masaryk University

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

65

Start Date

2024-05-01

Completion Date

2027-12-31

Last Updated

2025-03-13

Healthy Volunteers

No

Conditions

Interventions

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