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临床试验/NCT04940429
NCT04940429终止不适用

Oculometric Assessment of Dynamic Visual Processing in Patients With Obesity and the Impact of Bariatric Surgery

Stanford University1 个研究点 分布在 1 个国家目标入组 19 人开始时间: 2018年11月27日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
19
试验地点
1
主要终点
Change in Nfit score

研究概览

简要总结

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.

详细描述

This study will involve the utilization of a noninvasive computer application (Neurofit) to perform oculometric assessment of dynamic visual processing . Eye movements are short latency, voluntary motor behaviors that consist of various aspects including visual motion, pursuit initiation, steady-state tracking, direction tuning, and speed tuning. The computer application is based on an eye movement methodology that can quantify many aspects of human dynamic visual processing using a noninvasive video-based eye tracking technology with validated oculometric analysis techniques. It captures 8 domains of oculometric function and reports a composite score (NFit).

Prior studies have demonstrated sensorimotor dysfunction in patients with diffuse brain injury which leads to derangement in information processing throughout the brain. This computer application has been utilized in patients with traumatic brain injury (TBI). Liston et al, in a study of 34 TBI patients, demonstrated that TBI patients had several individual oculometrics that were significantly deranged including pursuit latency, initial pursuit acceleration, pursuit gain, catch-up saccade amplitude, proportion smooth tracking, and speed responsiveness.

By comparing individual and composite oculometric data between patients before and after weight-loss surgery, this research study hopes to identify any significant differences or distinct patterns that may exist as a result of obesity. We also intend to compare changes in high-sensitivity CRP to assess if post-surgical changes in this inflammatory marker correlates with improvement in dynamic visual processing. Patients seen in our bariatric surgery clinic are primarily offered Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) as surgical weight loss options. These two procedures are different in that while both provide significant weight loss, the hormonal effects are different between procedures. For this reason, patients undergoing both surgeries will be recruited to determine any differences in oculometrics and serum biomarkers by surgery type. Liver histology data will be obtained per chart review if previously available. This data will be used to ascertain the existence of fatty liver disease, steatohepatitis and/or cirrhosis.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • 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

结局指标

主要结局

Change in Nfit score

时间窗: Baseline to 1 year post operatively

Composite oculometric testing score on Neurofit

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

POkafor

Clinical Assistant Professor

Stanford University

研究点 (1)

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