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临床试验/NCT04940416
NCT04940416终止不适用

Oculometric Testing for the Diagnosis of Covert Hepatic Encephalopathy

Stanford University1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2017年8月31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
48
试验地点
1
主要终点
NeuroFit score

研究概览

简要总结

This study involves utilizing a noninvasive computer application (Neurofit) that performs oculometric assessment of dynamic visual processing in patients with liver cirrhosis to see if the presence of advance liver disease influences eye movement metrics.

详细描述

Cirrhosis is an increasingly prevalent medical condition in the United States that impacts health-related quality of life, healthcare resource utilization and survival. Patients with decompensated cirrhosis occasionally suffer from hepatic encephalopathy which is a serious complication that results from portosystemic shunting of blood leading to a spectrum of neuropsychiatric changes and alteration in consciousness levels when it becomes overt (overt hepatic encephalopathy, OHE).

Hepatic encephalopathy affects 30-45% of patients with cirrhosis and its occurrence and progression is associated with higher mortality.

In particular, Hepatic encephalopathy (HE) is an independent predictor of hospital readmissions in patients with cirrhosis. Encephalopathy could be overt with obvious deterioration in the level of consciousness leading to hospitalizations, but could also be covert and less obvious to the patient and healthcare provider.

Covert hepatic encephalopathy (CHE) is often unrecognized by healthcare providers leading to falls, motor vehicular accidents, and potential progression to overt confusion. Progression of CHE to OHE makes recognition of this condition important as early identification and treatment can potentially improve quality of life, reduce hospital readmissions and healthcare costs. Existing diagnostic tools are not only tedious and time consuming, but also impacted by factors such as level of education, reducing their utility in clinical practice. The ideal test would be easy to use, quantifiable, quick, cheap, reliable, and able to predict outcomes.

The exploratory study will utilize a noninvasive computer application (Neurofit) that performs 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.

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 with cirrhosis with clinical appointments in the pretransplant liver clinic
  • Patients in the general gastroenterology clinic without a diagnosis of cirrhosis (controls)

排除标准

  • Individuals <18 years
  • cirrhotic patients with hepatocellular cancer
  • individuals with uncontrolled neuropsychiatric illnesses or overt hepatic encephalopathy
  • ongoing alcohol or illicit substance use
  • non-English speakers, as the language barrier may impact psychometric test results

结局指标

主要结局

NeuroFit score

时间窗: at first visit (up to 5 minutes)

Composite oculometric test result

次要结局

  • Psychometric hepatic encephalopathy score(at first visit (up to 10 minutes))

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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