NCT Number: NCT07229924
Background: Obesity is a chronic, systemic, and multifactorial disease affecting populations worldwide, with projections indicating a 50% increase by 2035. It is linked to higher risks of cognitive decline, brain atrophy, and neurodegenerative diseases like Alzheimer's. Bariatric surgery has shown benefits in reducing fat and systemic inflammation, which may improve cognitive function. However, the factors predicting such improvements remain unclear.
Objective: To evaluate the effect of bariatric surgery on cognitive performance using virtual reality (Neurotracker) and the Neuropsi neuropsychological battery.
Methods: This prospective quasi-experimental study will include patients with morbid obesity who are candidates for bariatric surgery. Cognitive performance will be evaluated using the Neurotracker virtual reality tool and the Neuropsi neuropsychological battery. Participants will complete Neurotracker sessions three times weekly for two weeks before surgery, and again at 3- and 6-months post-surgery. The Neuropsi assessment will be conducted once prior to surgery and repeated at 6 months afterward. Statistical analyses will compare cognitive performance before and after the surgical intervention.
Expected Outcomes: The study aims to identify measurable improvements in cognitive function after weight loss from bariatric surgery, evaluated through both traditional neuropsychological tests and immersive virtual reality tools. These results could improve understanding of the cognitive benefits of surgical obesity treatment and the factors that predict these outcomes.
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Not applicable
Faubert Lab, Montreal, Quebec, Canada
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
A. Age (18-65 years) B. Diagnostic of morbid obesity with a body mass index (BMI) > 40 kg/m2, or, C. Obesity grade II (BMI > 35 kg/m2) and associated comorbidities (Diabetes Mellitus type 2, Hypertension, Ischemic Cardiopathy, Hyperlipidemia, Hepatic Steatosis, Metabolic Syndrome, Obstructive Sleep Apnea, Pickwick Syndrome) D. Bariatric surgery criteria.
Exclusion criteria
A. Age < 18 years, > 65 years B. Visual impairment C. Personal history of CVE D. Drug addiction.
Surgical procedures designed to induce sustained weight loss in patients with morbid obesity by modifying the gastrointestinal anatomy to restrict caloric intake, reduce nutrient absortion, or alter gut hormonal responses involved in appetite and metabolism regulation.
Time frame: NEUROPSI will be applied to group intervention before bariatric surgery and 6 months after it. For the control group, NEUROPSI will be applied at the time of enrollment and 6 months later.
NEUROPSI is a standardized neuropsychological assessment battery designed to evaluate cognitive functions. It provides quantitative measures adjusted for age and education grade.
Time frame: The time of evaluation will be: 12 sessions pre-surgery, 12 sessions, 3 months post-surgery (post-op) 12 sessions, 6 months post-op With a total of 3 visits per evaluation (9 visits), each patient will complete 80 trials per visit.
has a virtual cloud-based web portal, that has been validated by functional Magnetic Resonance Imaging. Participants will perform a total of 12 sessions. Each session will consist of 3 blocks of 20 trials.
Contact information is provided by the study sponsor or research team.
Hospital General de México Dr. Eduardo Liceaga
Other Gov
Effect of Bariatric Surgery on Cognitive Performance Assessed Using a Virtual Reality Program and the Neuropsi Battery.
Acronym: CognitiveBS
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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