Flicker App for Minimal Hepatic Encephalopathy

Evaluating a Novel, Self-administered Device (Flicker-App) That Measures Critical Flicker Frequency as a Test for Minimal Hepatic Encephalopathy in Cirrhosis

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04415294

Enrollment

Registered

2020-06-04

Start date

2019-10-22

Completion date

2023-06-30

Last updated

2022-01-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Encephalopathy

Brief summary

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

Detailed 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

Interventions

DIAGNOSTIC_TESTCritical flicker frequency

Measure the critical flicker frequency as a screening test for hepatic encephalopathy using a portable self administered device

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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).

Design outcomes

Primary

Measure	Time frame	Description
CFF Agreement	1 day	Level of agreement between Flicker App CFF and gold-standard device

Countries

United States

Contacts

Primary ContactMichael Yacoub

yacoum@washington.medicine.edu2067443402

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026