NCT07229924

Brief Summary

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2024

Geographic Reach
2 countries

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 25, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 25, 2025

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 17, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2026

Completed
Last Updated

November 17, 2025

Status Verified

November 1, 2025

Enrollment Period

1 year

First QC Date

November 13, 2025

Last Update Submit

November 13, 2025

Conditions

Keywords

Bariatric SurgeryCognitionNeuroTrackerNeuropsiObesity

Outcome Measures

Primary Outcomes (2)

  • NEUROPSI

    NEUROPSI is a standardized neuropsychological assessment battery designed to evaluate cognitive functions. It provides quantitative measures adjusted for age and education grade.

    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.

  • NeuroTracker

    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.

    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.

Study Arms (2)

Control group

NO INTERVENTION

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

Intervention/Treatment

EXPERIMENTAL

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

Procedure: Bariatric Surgery

Interventions

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/Treatment

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • A. Age \< 18 years, \> 65 years B. Visual impairment C. Personal history of CVE D. Drug addiction.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faubert Lab

Montreal, Quebec, H3T 1P1, Canada

WITHDRAWN

Hospital General de México "Dr. Eduardo Licega"

Mexico City, Mexico City, 06720, Mexico

RECRUITING

Related Publications (6)

  • 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.

    PMID: 23761025BACKGROUND
  • Oria HE, Moorehead MK. Bariatric analysis and reporting outcome system (BAROS). Obes Surg. 1998 Oct;8(5):487-99. doi: 10.1381/096089298765554043.

    PMID: 9819079BACKGROUND
  • 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.

    PMID: 36767489BACKGROUND
  • 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.

    PMID: 17848126BACKGROUND
  • 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.

    PMID: 32115585BACKGROUND
  • 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.

    PMID: 38060949BACKGROUND

Related Links

MeSH Terms

Conditions

Obesity

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

BariatricsObesity ManagementTherapeuticsSurgical Procedures, Operative

Study Officials

  • Argelia Pérez Pacheco, PhD

    Hospital General de México Dr. Eduardo Liceaga

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Argelia Pérez Pacheco, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher

Study Record Dates

First Submitted

November 13, 2025

First Posted

November 17, 2025

Study Start

June 25, 2024

Primary Completion

June 25, 2025

Study Completion

March 1, 2026

Last Updated

November 17, 2025

Record last verified: 2025-11

Data Sharing

IPD Sharing
Will not share

Locations