Speech in Hepatic Encephalopathy (HE)

University of Michigan251 enrolled

Overview

This is an observational study that will test the clinical significance of speech features in patients with cirrhosis. It aims to assess if speech is associated with cognitive function at baseline, if speech predicts changes in cognition, and if speech predicts future events of hepatic encephalopathy (cirrhosis-related confusion), as well as to assess the dynamics of speech over time, especially with episodes of overt hepatic encephalopathy (OHE) and treatment interventions.

Study Type

OBSERVATIONAL

Enrollment

251

Conditions

Hepatic Encephalopathy

Interventions

Home RecordingsBEHAVIORAL

If patients are willing to download the Winterlight application to their personal iOS devices this will be done at study visit 1. The application will send a notification to the patient once per month, requesting that they perform a paragraph reading task, a picture description task, and an animal naming task.

In-patient RecordingsBEHAVIORAL

If patients are admitted to UM hospital for suspected or confirmed OHE, with patient assent, physician study staff will assist the patient in recording a paragraph reading task, a picture description task, and an animal naming task.

Same-Day Study Visit - Regular AppointmentBEHAVIORAL

Staff will call patients in anticipation of in-person regular visits to set up a same-day study visit. Patients will record the three speech tasks at this time.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria for Patients with Cirrhosis: * Cirrhosis, as diagnosed by imaging, elastography, biopsy, or decompensation * Able to provide informed consent in English Exclusion Criteria for Patients with Cirrhosis: * Neurodegenerative disorder (other than hepatic encephalopathy) including Alzheimer's disease and dementia * Prior stroke or Transischemic Attack (TIA) * English not primary language for communication Inclusion Criteria for Patients without Cirrhosis: * Able to provide informed consent in English * Fibroscan with stiffness \<7 kPa Exclusion Criteria for Patients without Cirrhosis: * Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) \>5 times the upper limit of normal in the last year * History of cirrhosis by imaging or histology or clinical decompensation * Neurodegenerative disorder (other than hepatic encephalopathy) including Alzheimer's disease and dementia * Prior stroke or TIA

Locations (1)

University of Michigan Hepatology and Transplant Clinic

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

Change in Psychometric Hepatic Encephalopathy Score (PHES) from Baseline to 6 Months

A well-validated pen-and-paper neurocognitive assessment tool to identify minimal Hepatic Encephalopathy (HE). Scores range from -15 to +5; values farther from 0 (normalized average) represent more significant deviation from the norm. Positive scores indicate better performance.

Time frame: 6 Months

Change in Psychometric Hepatic Encephalopathy Score (PHES) from Baseline to 12 Months

Time frame: 12 Months

Speech Assessments

Recorded speech tasks comprising 3 sections: paragraph reading test, picture description test, and animal naming test.

Time frame: 12 Months

Time to Overt Hepatic Encephalopathy (HE)

Patient-reported HE episodes and HE episodes resulting in patient admission to University of Michigan hospital. Information collected includes: Date of symptom onset, duration of HE episode, and changes to medications.

Time frame: 12 Months

Data from ClinicalTrials.gov

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