Eye Movement Testing for Diagnosing Encephalopathy in Patients With Liver Disease

NCT04940416 | Terminated FDA Device

• 1 other identifier: 41796
• Study Type: observational
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cirrhosis; Hepatic Encephalopathy

Outcome Measures

Primary Outcomes (1)

• NeuroFit score

  Composite oculometric test result

  at first visit (up to 5 minutes)

Secondary Outcomes (1)

• Psychometric hepatic encephalopathy score

  at first visit (up to 10 minutes)

Study Arms (2)

Cirrhosis

These will include patients with cirrhosis. They will perform the paper-based standard psychometric tests (number connection test A, number connection test B, line tracing test, and digital subtraction test, and serial dotting test, which take about 20 minutes). After completion of paper-based standard psychometric tests, participants will then perform the computer application test which takes about 5 minutes.

Device: Neurofit (oculometric testing)

Non-cirrhosis

These will include patients without cirrhosis seen in the general gastroenterology clinic. Participants will perform the paper-based standard psychometric tests (number connection test A, number connection test B, line tracing test, and digital subtraction test, and serial dotting test, which take about 20 minutes). After completion of paper-based standard psychometric tests, participants will then perform the computer application test which takes about 5 minutes.

Device: Neurofit (oculometric testing)

Interventions

Neurofit (oculometric testing) DEVICE

The Neurofit test 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. The total time for completion of all the tests is estimated at 30 minutes.

Cirrhosis; Non-cirrhosis

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include consenting patients with cirrhosis seen in the gastroenterology and hematology clinic of the Stanford hospital. They will include patients with cirrhosis of varying severity. The non cirrhosis arm will include patients in the general gastroenterology clinic with no laboratory or radiological evidence of cirrhosis.

You may qualify if:

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

You may not qualify if:

• 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

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

Fibrosis; Hepatic Encephalopathy

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

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: August 31, 2017
• 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)