Analysis of Acoustic, Lexical, and Syntactic Speech Features in Hepatic Encephalopathy
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Hepatic Encephalopathy
- Sponsor
- University of Michigan
- Enrollment
- 251
- Locations
- 1
- Primary Endpoint
- Change in Psychometric Hepatic Encephalopathy Score (PHES) from Baseline to 6 Months
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Patricia Bloom
Assistant Professor
University of Michigan
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in Psychometric Hepatic Encephalopathy Score (PHES) from Baseline to 6 Months
Time Frame: 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.
Change in Psychometric Hepatic Encephalopathy Score (PHES) from Baseline to 12 Months
Time Frame: 12 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.
Speech Assessments
Time Frame: 12 Months
Recorded speech tasks comprising 3 sections: paragraph reading test, picture description test, and animal naming test.
Time to Overt Hepatic Encephalopathy (HE)
Time Frame: 12 Months
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.