Clinical trial

Evaluation of Cognitive Improvement After Bariatric Surgery Using a Virtual Reality Program and the Neuropsi Neuropsychological Battery

Recruiting now · Not applicable · 2 countries · Registry ID NCT07229924

Recruiting nowNot applicableInterventional

What this study is about

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.

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years

SexAll

Healthy volunteersAccepted

ConditionObesity (Disorder), Obesity and Obesity-related Medical Conditions

Full registry criteria

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.

Treatments and study arms

Bariatric Surgery

Procedure

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.

Primary outcomes

NEUROPSINEUROPSI 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.

NeuroTrackerThe 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.

Study locations

2 locations were listed when this page was built. The first 40 are shown.

Faubert Lab🇨🇦 Montreal, Quebec, Canada

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Hospital General de México "Dr. Eduardo Licega"🇲🇽 Mexico City, Mexico City, Mexico

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Argelia Pérez Pacheco, PhDContact

Email · Call 5527892000

Adriana Lizzet Gutiérrez Guerrero, MDSub Investigator

Carlos Pérez Duarte Rosas, MDSub Investigator