Obesity (Disorder)CognitiveBSNCT07229924
Evaluation of Cognitive Improvement After Bariatric Surgery Using a Virtual Reality Program and the Neuropsi Neuropsychological Battery
A study testing Bariatric Surgery in people with Obesity (Disorder) and Obesity and Obesity-related Medical Conditions, run by Hospital General de México Dr. Eduardo Liceaga at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity (Disorder), Obesity and Obesity-related Medical Conditions
- What is being tested?
- Bariatric Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 25 Jun 2024to 1 Mar 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Age < 18 years, > 65 years B. Visual impairment C. Personal history of CVE D. Drug addiction.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Mexico1 site, 1 recruiting
- Recruiting
Hospital General de México "Dr. Eduardo Licega"
Mexico City, Mexico City, 06720
Argelia Pérez Pacheco, PhD, 5527892000 ext. 1242, argeliapp@ciencias.unam.mx
Adriana Lizzet Gutiérrez Guerrero, MD
About this study
Official title: 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.
Read more
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.
- Being tested
- Bariatric Surgery
- Keywords
- Bariatric Surgery, Cognition, NeuroTracker, Neuropsi, Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric SurgeryProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Bariatric Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
NEUROPSI
NEUROPSI is a standardized neuropsychological assessment battery designed to evaluate cognitive functions. It provides quantitative measures adjusted for age and education grade.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2025
- Study start25 Jun 2024
- Primary completion25 Jun 2025
- Study completion1 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Obesity (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital General de México Dr. Eduardo Liceaga
- Sponsor type
- Other government
- Collaborators
- Université de Montréal, NeuroTracker Athletics Inc.
- Responsible party
- Principal investigator, Argelia Pérez Pacheco, Hospital General de México Dr. Eduardo Liceaga
- Investigators
- Argelia Pérez Pacheco, PhD, Principal investigator, Hospital General de México Dr. Eduardo Liceaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07229924
- Sponsor's protocol ID
- DI/24/501/04/37
- Other IDs
- DI/24/501/04/37
- Acronym
- CognitiveBS
- Status last verified
- Nov 2025
- First submitted
- 13 Nov 2025
- Last updated
- 17 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23761025Oria HE, Moorehead MK. Bariatric analysis and reporting outcome system (BAROS). Obes Surg. 1998 Oct;8(5):487-99. doi: 10.1381/096089298765554043.
PubMed 9819079Hachula 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.
PubMed 36767489Ostrosky-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.
PubMed 17848126Frigolet 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.
PubMed 32115585Campos-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.
PubMed 38060949
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bariatric Surgery on Cognitive Performance Assessed Using a Virtual Reality Program and the Neuropsi Battery.
- ClinicalTrials.gov ID
- NCT07229924
- Acronym / sponsor ID
- CognitiveBS / DI/24/501/04/37
- Keywords
- Bariatric Surgery, Cognition, NeuroTracker, Neuropsi, Obesity
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Hospital General de México Dr. Eduardo LiceagaOther government
- Collaborators
- Université de Montréal, NeuroTracker Athletics Inc.
- Study start
- 25 Jun 2024 (actual)
- Primary completion
- 25 Jun 2025 (actual)
- Study completion
- 1 Mar 2026 (estimated)
- First posted
- 17 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –Evaluation of perceptual-cognitive functions (NeuroTracker) in individuals without obesity. |
| Intervention/Treatment | Experimental | Procedure: Bariatric SurgeryEvaluation of perceptual-cognitive functions (NeuroTracker) in patients with morbid obesity or obesity and related conditions, who were treated with bariatric surgery. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Age < 18 years, > 65 years B. Visual impairment C. Personal history of CVE D. Drug addiction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bariatric SurgerySurgical 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. | Procedure or surgery | Intervention/Treatment |
Primary outcome
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.
NEUROPSI is a standardized neuropsychological assessment battery designed to evaluate cognitive functions. It provides quantitative measures adjusted for age and education grade.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2025.
- Background: PubMed 23761025Legault 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.
- Background: PubMed 9819079Oria HE, Moorehead MK. Bariatric analysis and reporting outcome system (BAROS). Obes Surg. 1998 Oct;8(5):487-99. doi: 10.1381/096089298765554043.
- Background: PubMed 36767489Hachula 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.
- Background: PubMed 17848126Ostrosky-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.
- Background: PubMed 32115585Frigolet 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.
- Background: PubMed 38060949Campos-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.
- Link to the official NeuroTracker website.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Argelia Pérez Pacheco, PhD principal investigator
Hospital General de México Dr. Eduardo Liceaga
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bariatric Surgery in people with Obesity (Disorder) and Obesity and Obesity-related Medical Conditions, run by Hospital General de México Dr. Eduardo Liceaga at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada, Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Argelia Pérez Pacheco, PhD (+525527892000 ext. 1242, argeliapp@ciencias.unam.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07229924, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2025.