Speech in Hepatic Encephalopathy (HE)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Patients with Cirrhosis This group will be composed of 200 patients with cirrhosis. Patients will be enrolled regardless of compensated vs. decompensated status, prior history of HE, Model for End Stage Liver Disease (MELD), and cirrhosis etiology. |
Behavioral: Home Recordings
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.
Behavioral: In-patient Recordings
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.
Behavioral: Same-Day Study Visit - Regular Appointment
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.
Behavioral: Same-Day Study Visit - Procedure
Staff will call patients in anticipation of in-person procedure visits to set up a same-day study visit, prior to procedure if sedation is planned. Patients will record the three speech tasks at this time.
Behavioral: Phone Call Follow-up Visits
Non-physician study staff will call the patients every 3 months and, using a phone script, will ask them survey questions about their hepatic health.
|
| Patients without Cirrhosis This group will be composed of 50 patients without cirrhosis to act as controls. They will have been found on Fibroscan to not have significant fibrosis. |
Behavioral: Home Recordings
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.
Behavioral: Same-Day Study Visit - Regular Appointment
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.
|
Outcome Measures
Primary Outcome Measures
- Change in Psychometric Hepatic Encephalopathy Score (PHES) from Baseline to 6 Months [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 [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 [12 Months]
Recorded speech tasks comprising 3 sections: paragraph reading test, picture description test, and animal naming test.
- Time to Overt Hepatic Encephalopathy (HE) [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.
Eligibility Criteria
Criteria
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
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Neurodegenerative disorder (other than hepatic encephalopathy) including Alzheimer's disease and dementia
-
Prior stroke or TIA
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Michigan Hepatology and Transplant Clinic | Ann Arbor | Michigan | United States | 48109 |
Sponsors and Collaborators
- University of Michigan
- Winterlight Labs
Investigators
- Principal Investigator: Patricia Bloom, MD, University of Michigan
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HUM00191626