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

NCT ID: NCT07229924

Last Updated: 2025-11-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-25

Study Completion Date

2026-03-01

Brief Summary

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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.

Detailed Description

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Conditions

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Obesity (Disorder) Obesity and Obesity-related Medical Conditions

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Control group

Evaluation of perceptual-cognitive functions (NeuroTracker) in individuals without obesity.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention/Treatment

Evaluation of perceptual-cognitive functions (NeuroTracker) in patients with morbid obesity or obesity and related conditions, who were treated with bariatric surgery.

Group Type EXPERIMENTAL

Bariatric Surgery

Intervention Type 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.

Interventions

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Bariatric Surgery

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Université de Montréal

OTHER

Sponsor Role collaborator

NeuroTracker Athletics Inc.

UNKNOWN

Sponsor Role collaborator

Hospital General de México Dr. Eduardo Liceaga

OTHER_GOV

Sponsor Role lead

Responsible Party

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Argelia Pérez Pacheco

Researcher

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Argelia Pérez Pacheco, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital General de México Dr. Eduardo Liceaga

Locations

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Faubert Lab

Montreal, Quebec, Canada

Site Status WITHDRAWN

Hospital General de México "Dr. Eduardo Licega"

Mexico City, Mexico City, Mexico

Site Status RECRUITING

Countries

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Canada Mexico

Central Contacts

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Argelia Pérez Pacheco, PhD

Role: CONTACT

+525527892000 ext. 1242

Facility Contacts

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Argelia Pérez Pacheco, PhD

Role: primary

5527892000 ext. 1242

References

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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.

Reference Type BACKGROUND
PMID: 23761025 (View on PubMed)

Oria HE, Moorehead MK. Bariatric analysis and reporting outcome system (BAROS). Obes Surg. 1998 Oct;8(5):487-99. doi: 10.1381/096089298765554043.

Reference Type BACKGROUND
PMID: 9819079 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36767489 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17848126 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32115585 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 38060949 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Related Links

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https://es.neurotrackerx.com/

Link to the official NeuroTracker website.

Other Identifiers

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DI/24/501/04/37

Identifier Type: OTHER

Identifier Source: secondary_id

DI/24/501/04/37

Identifier Type: -

Identifier Source: org_study_id

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