- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07229924
Evaluation of Cognitive Improvement After Bariatric Surgery Using a Virtual Reality Program and the Neuropsi Neuropsychological Battery (CognitiveBS)
Effect of Bariatric Surgery on Cognitive Performance Assessed Using a Virtual Reality Program and the Neuropsi Battery.
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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Argelia Pérez Pacheco, PhD
- Phone Number: 1242 +525527892000
- Email: argeliapp@ciencias.unam.mx
Study Locations
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Quebec
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Montreal, Quebec, Canada, H3T 1P1
- Withdrawn
- Faubert Lab
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Mexico City
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Mexico City, Mexico City, Mexico, 06720
- Recruiting
- Hospital General de México "Dr. Eduardo Licega"
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Contact:
- Argelia Pérez Pacheco, PhD
- Phone Number: 1242 5527892000
- Email: argeliapp@ciencias.unam.mx
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Sub-Investigator:
- Adriana Lizzet Gutiérrez Guerrero, MD
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Sub-Investigator:
- Carlos Pérez Duarte Rosas, MD
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Sub-Investigator:
- María Fernanda García Ortega, MD
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Sub-Investigator:
- Samuel González Juárez, MD
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Sub-Investigator:
- José Manuel González Ramírez, MD
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Sub-Investigator:
- Jazmín Verónica Ávila Lozano, MD
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Sub-Investigator:
- Antonio González Chávez, MD
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Sub-Investigator:
- Karla Janeth Torres Rayón, BS
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Sub-Investigator:
- David Trejo Martínez, MS
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Control group
Evaluation of perceptual-cognitive functions (NeuroTracker) in individuals without obesity.
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|
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Experimental: Intervention/Treatment
Evaluation of perceptual-cognitive functions (NeuroTracker) in patients with morbid obesity or obesity and related conditions, who were treated with bariatric surgery.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
NEUROPSI
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.
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NEUROPSI is a standardized neuropsychological assessment battery designed to evaluate cognitive functions.
It provides quantitative measures adjusted for age and education grade.
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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.
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NeuroTracker
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.
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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.
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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.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Argelia Pérez Pacheco, PhD, Hospital General de México Dr. Eduardo Liceaga
Publications and helpful links
General Publications
- Oria HE, Moorehead MK. Bariatric analysis and reporting outcome system (BAROS). Obes Surg. 1998 Oct;8(5):487-99. doi: 10.1381/096089298765554043.
- Legault I, Allard R, Faubert J. Healthy older observers show equivalent perceptual-cognitive training benefits to young adults for multiple object tracking. Front Psychol. 2013 Jun 6;4:323. doi: 10.3389/fpsyg.2013.00323. eCollection 2013.
- Hachula M, Kosowski M, Zielanska K, Basiak M, Okopien B. The Impact of Various Methods of Obesity Treatment on the Quality of Life and Mental Health-A Narrative Review. Int J Environ Res Public Health. 2023 Jan 24;20(3):2122. doi: 10.3390/ijerph20032122.
- Ostrosky-Solis F, Esther Gomez-Perez M, Matute E, Rosselli M, Ardila A, Pineda D. NEUROPSI ATTENTION AND MEMORY: a neuropsychological test battery in Spanish with norms by age and educational level. Appl Neuropsychol. 2007;14(3):156-70. doi: 10.1080/09084280701508655.
- Frigolet ME, Dong-Hoon K, Canizales-Quinteros S, Gutierrez-Aguilar R. Obesity, adipose tissue, and bariatric surgery. Bol Med Hosp Infant Mex. 2020;77(1):3-14. doi: 10.24875/BMHIM.19000115.
- Campos-Nonato I, Galvan-Valencia O, Hernandez-Barrera L, Oviedo-Solis C, Barquera S. Prevalencia de obesidad y factores de riesgo asociados en adultos mexicanos: resultados de la Ensanut 2022. Salud Publica Mex. 2023 Jun 14;65:s238-s247. doi: 10.21149/14809. Spanish.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DI/24/501/04/37 (Other Identifier: Hospital General de México, Dr. Eduardo Liceaga)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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