Non-invasive Brain Stimulation to Prepare the Patient for Bariatric Surgery (REBAS)
NCT06874309 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 65
Last updated 2025-03-13
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.
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.
Sponsors & Collaborators
-
St. Anne´s University Hospital Brno
collaborator UNKNOWN -
Masaryk University
lead OTHER
Principal Investigators
-
Irena Rektorová, Prof. · Cetral European Institute of Technology
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-05-01
- Primary Completion
- 2026-12-31
- Completion
- 2027-12-31
Countries
- Czechia
Study Locations
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