Development of a Novel Vocal Biomarker in the Diagnosis and Management of Hepatic Encephalopathy

Overview

About this study

Hepatic encephalopathy (HE) is a serious complication of cirrhotic stage liver disease. It is reported that 30-70% of all patients with cirrhosis have HE. The current diagnostic methodology for HE includes a blood lab monitoring of ammonia and neuropsychometric testing, which can define the diagnosis but cannot assess the vitally important daily variability of this complication.

There are, however, distinct cognitive neurologic findings in HE that could be mapped and exploited for quick and accurate daily assessment. Vocal changes and speech analysis may provide guidance in the diagnosis and management of HE. The computer algorithm calculating vocal changes in HE would be valuable not only for diagnosis but also for monitoring and adjusting therapy based on its results and recommendations. Currently, those diagnoses or therapeutic adjustments are made only through personal, wholly subjective assessment of ill-defined symptoms.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

18 years or older.
Presence of hepatic encephalopathy.
Controls healthy and those with cirrhosis but no evidence of HE.

Exclusion Criteria:

Patients unable to provide consent or without a care giver able to provide consent.
Patients younger than 18 years.
Patients with a diagnosis of other neurologic diseases such as Parkinson’s disease, dementia or Wernicke-Korsakoff syndrome, concern for intracerebral hemorrhage or CNS sepsis.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Jacksonville, Fla. Mayo Clinic principal investigator Denise Harnois, D.O.	Open for enrollment	Contact information: Denise Harnois D.O. (904) 956-3200 harnois.denise@mayo.edu

Mayo Clinic Location

Status

Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Denise Harnois, D.O.

Open for enrollment

Contact information:

Denise Harnois D.O.

(904) 956-3200

harnois.denise@mayo.edu

More information

Publications

Publications are currently not available

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