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Eye Movement Testing in Patients With Obesity and the Impact of Weight Loss Surgery

NCT04940429 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 19

Last updated 2021-06-25

No results posted yet for this study

Summary

Obesity is a condition of chronic low-grade inflammation, thought to be secondary to adipose tissue secretion of cytokines including interleukin 6 (IL-6), and tumor necrosis factor alpha (TNF- α) which effect multiple pathways and lead to an increase in C-reactive protein (CRP), a sensitive marker of systemic inflammation. Chronic inflammation is thought to be a major risk factor for the development of metabolic syndrome, diabetes, cardiovascular disease and cancer. Inflammatory cytokines have also been shown to directly and indirectly interact with the central nervous system influencing behavior and neural activity.

Obesity is an independent risk factor for reduced cognitive function including poor attention, executive function and memory. Demonstrating improvement in dynamic visual processing following bariatric surgery could expand our understanding of the impact of obesity on central nervous system (CNS) function.

Conditions

  • Bariatric Surgery Candidate
  • Obesity, Morbid

Interventions

DEVICE

Neurofit

This involves sitting on a chair with a head and chin rest to maintain stability. Patients will then follow a moving object on the computer screen with their eyes which allows estimation of individual oculometrics along with a composite score. No physical contact or placement of invasive devices will be performed.

DIAGNOSTIC_TEST

Psychometric hepatic encephalopathy score

During the number connection tests, the participant is asked to join dots between numbers or numbers and letters in a timed fashion and the number of seconds required is the outcome. In the line tracing test, participants are required to trace a line between two parallel lines and the time required is noted. Also, the number of times the subject strays outside the line (line tracing test error) is captured. In the digit symbol test, participants are required to pair numbers with special symbols. An individual's score reflects the number of correct pairs achieved in 120 seconds. In the serial dotting test, participants are asked to dot the center of a group of blank circles and the time required to complete the test is the outcome. Psychometric tests will be completed at their post-operative visits.

Sponsors & Collaborators

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-27
Primary Completion
2021-06-17
Completion
2021-06-17
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04940429 on ClinicalTrials.gov