Feasibility of Critical Flicker Frequency Procedure for the Diagnosis of Minimal Encephalopathy

A Pilot Study Aiming to Assess the Feasibility of Critical Flicker Frequency for the Diagnosis of Minimal Encephalopathy in Patients With Cirrhosis

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01080144

Enrollment

Registered

2010-03-03

Start date

2009-10-31

Completion date

2012-12-31

Last updated

2017-05-11

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

Conditions

Cirrhosis

Keywords

Cirrhosis, TIPS (Transjugular intrahepatic portosystemic shunt), Encephalopathy

Brief summary

All patients eligible for TIPS (Transjugular intrahepatic portosystemic shunt) procedure will be considered for inclusion. After written inform consent, psychometric tests in order to calculate the psychometric hepatic encephalopathy (PHES) score, the gold standard for the diagnosis of minimal encephalopathy and critical flicker frequency (CFF) will be performed before the TIPS procedure. After TIPS, patients will be followed during one year and the psychometric test and CFF will be performed every 3 months. 30 patients will be included. The main endpoint is the success rate of CFF. The secondary end points are * Correlation between CFF and PHES score * Performance of CFF and PHES score to predict the occurrence of overt encephalopathy after TIPS procedure * A sample collection during TIPS procedure is also performed for validation of biomarkers

Interventions

OTHERCritical flicker frequency procedure

After TIPS, patients will be followed during one year and the psychometric test and Critical flicker frequency procedure will be performed every 3 months

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* patients with cirrhosis in whom a TIPS is indicated * patients have given their informed consent te be included

Exclusion criteria

* minor * pregnant women * patients who cannot see the red color * refusal to participate

Design outcomes

Primary

Measure	Time frame	Description
success rate of Critical Flicker Frequency (CFF) Procedure	before TIPS and every 3 months till one year	number of patients in whom ten measurement will be available / 30 patients

Secondary

Measure	Time frame
occurrence of encephalopathy	every 3 months till one year after TIPS procedure

Countries

France

Outcome results

None listed

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