Flicker App for Minimal Hepatic Encephalopathy

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University of Washington

Status

Enrolling

Conditions

Hepatic Encephalopathy

Treatments

Diagnostic Test: Critical flicker frequency

Study type

Observational

Funder types

Other
NIH

Identifiers

NCT04415294
R21DK117431 (U.S. NIH Grant/Contract)
STUDY00004521

Details and patient eligibility

About

There is a great unmet clinical need for improved screening for MHE in patients with cirrhosis. We will demonstrate that the Flicker-App can be used in clinic as well as at home by patients with cirrhosis to measure CFF, a proven screening test for MHE. We will optimize the protocol, software, and hardware of the Flicker-App to create a product appropriate for production and distribution to patients

Full description

SA 1. Determine whether cirrhotic patients (n=75) can self-administer the Flicker-App in clinic supervised by a research assistant and calculate the level of agreement between the CFF determined by the Flicker-App, the CFF determined by the "gold-standard" FFS device, and the test scores on the EncephalApp Stroop test. SA 2. Determine whether cirrhotic patients (n=75) can self-administer the Flicker-App at home, including daily measurements over 1 week and weekly measurements over 6 weeks, and calculate the adherence to this protocol and the variability of these CFF measurements. SA3. Make any necessary software or hardware adjustments to the Flicker-App to facilitate and simplify its self-administration by patients based on structured interview-questionnaires with the study participants and with clinical Gastroenterologists/Hepatologists

Enrollment

75 estimated patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Cirrhosis (standard criteria)
  • Chronic liver disease

Exclusion criteria

  • Grade III or IV hepatic encephalopathy
  • Mini-mental state examination score ≤25 (suggestive of dementia)
  • alcohol or illicit drug use within 3 months
  • current use of benzodiazepines
  • antiepileptics or psychotropic drugs
  • color blindness
  • severe vision impairment (blindness, macular degeneration).

Trial contacts and locations

1

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Central trial contact

Michael Yacoub

Data sourced from clinicaltrials.gov

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