Using brain stimulation to help patients prepare for weight loss surgery
Non-invasive Brain Stimulation to Prepare the Patient for Bariatric Surgery
This study is testing if brain stimulation can help people with severe obesity better control their eating habits before weight loss surgery to improve their chances of success.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 65 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Masaryk University Academic / other |
| Locations | 2 sites (Brno, Czechia and 1 other locations) |
| Trial ID | NCT06874309 on ClinicalTrials.gov |
What this trial studies
This study aims to improve the long-term success of bariatric surgery for severe obesity by using non-invasive brain stimulation (tDCS) to enhance cognitive control over eating behaviors before the surgery. Participants will receive either active or sham tDCS stimulation at home, and their brain function will be monitored before and after the surgery to assess changes associated with weight loss. The study focuses on individuals with a high body mass index (BMI) and those who struggle with controlling their eating habits, which can impact surgical outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals with severe or morbid obesity (BMI > 35 or 40) who exhibit disinhibition in their eating behaviors.
Not a fit: Patients with a history of heart disease, previous bariatric surgery, or those unable to comply with study procedures may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better weight loss outcomes and improved eating behaviors after bariatric surgery.
How similar studies have performed: While the use of brain stimulation in obesity treatment is a relatively novel approach, preliminary studies have shown promise in enhancing cognitive control and improving outcomes in similar contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Brno, Czechia and 1 other locations
- Saint Anne's University Hospital — Brno, Czechia, Czechia (Recruiting)
- Central European Institute of Technology Masaryk University — Brno, Czechia, Czechia (Recruiting)
Study contacts
- Principal investigator: Irena Rektorová, Prof. — Cetral European Institute of Technology
- Study coordinator: Petra Holštajn Zemánková, Dr.
- Email: petra.zemankova@mail.muni.cz
- Phone: +420 776 722 029
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.