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

NCT04940429 | Terminated FDA Device

• 1 other identifier: 45650
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Oculometrics

Outcome Measures

Primary Outcomes (1)

• Change in Nfit score

  Composite oculometric testing score on Neurofit

  Baseline to 1 year post operatively

Study Arms (2)

Roux n Y Gastric Bypass (RYGB)

Participants in this arm will include patients who will be having a RYGB after their assessment by their bariatric surgeon. After reviewing and signing the consent form, participants will perform the paper-based standard psychometric tests (number connection test A and B, line tracing test, and digital subtraction test, and serial dotting test, which take about 20 minutes) at their preoperative visit. After completion of paper-based standard psychometric tests, participants will then perform the computer application test which takes about 5 minutes at their preoperative visit. These will also be performed at their post operative visits 2 weeks, 3, 6 and 12 months.

Device: Neurofit; Diagnostic Test: Psychometric hepatic encephalopathy score

Sleeve gastrectomy (SG)

Participants in this arm will include patients who will be having a SG after their assessment by their bariatric surgeon. After reviewing and signing the consent form, participants will perform the paper-based standard psychometric tests (number connection test A and B, line tracing test, and digital subtraction test, and serial dotting test, which take about 20 minutes) at their preoperative visit. After completion of paper-based standard psychometric tests, participants will then perform the computer application test which takes about 5 minutes at their preoperative visit: These will also be performed at their post operative visits 2 weeks, 3, 6 and 12 months.

Device: Neurofit; Diagnostic Test: Psychometric hepatic encephalopathy score

Interventions

Neurofit DEVICE

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.

Roux n Y Gastric Bypass (RYGB); Sleeve gastrectomy (SG)

Psychometric hepatic encephalopathy score DIAGNOSTIC_TEST

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.

Roux n Y Gastric Bypass (RYGB); Sleeve gastrectomy (SG)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Obese patients being considered for weight loss surgery by their bariatric surgeons.

You may qualify if:

• Patients who are overweight or obese (Body Mass Index over 25 and 30, respectively)

You may not qualify if:

• Individuals \<18 years
• Patients with history of cognitive brain disease including traumatic brain injury, dementia, Parkinson's disease
• Individuals with uncontrolled neuropsychiatric illnesses or overt hepatic encephalopathy
• Ongoing alcohol or illicit substance use
• patients with cirrhosis

Sponsors & Collaborators

• Stanford University: lead
• Neurofit Inc, Mountain View, California: collaborator

Study Sites (1)

Stanford University School of Medicine

Redwood City, California, 94063, United States

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: June 17, 2021
• First Posted: June 25, 2021
• Study Start: November 27, 2018
• Primary Completion: June 17, 2021
• Study Completion: June 17, 2021
• Last Updated: June 25, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)