P300 in Early Cognitive Impairment in Hepatitis C Virus

Completed

• Conditions: Hepatitis C; Cognitive Impairment
• Interventions: Diagnostic Test: Visual Event-Related Potentials

• Registration Number: NCT04389268
• Lead Sponsor: Mansoura University Hospital

Brief Summary

Approximately 50% of patients with hepatitis C have complaints of fatigue and cognitive deficits even before the development of significant hepatic impairment.

Detailed Description

Assessing the influence of HCV infection on the development of cognitive changes involves many challenges. The frequent presence of confounding factors such as illicit drug use, depression, and cirrhosis has the potential to produce cognitive impairment and therefore obscuring the role of HCV infection as a major actor in the development of cognitive impairment.

The presence of brain dysfunction in patients with liver cirrhosis is well known. Zeegen et al. described in 1970, through the use of neuropsychological tests, the occurrence of cognitive changes involving mainly psychomotor speed, attention, and executive function in cirrhotics who did not have clinical criteria for hepatic encephalopathy. This condition is currently called minimal hepatic encephalopathy.

Study Timeline

• Study Start: 2018-02-01
• Primary Completion: 2019-01-01
• Study Completion: 2019-02-01
• Status Verified: 2020-05
• Study First Submitted: 2020-05-12
• Study First Submitted QC: 2020-05-12
• Last Update Submitted: 2020-05-12
• Study First Posted: 2020-05-15
• Last Update Posted: 2020-05-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Newly diagnosed HCV infection

Exclusion Criteria

• Any neuropsychiatric disease that cause impaired cognition

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control group	Visual Event-Related Potentials	Age and sex matched with patients
HCV patients	Visual Event-Related Potentials	Patients with uncomplicated newly diagnosed hepatitis C virus

Primary Outcome Measures

Name	Time	Method
Auditory P300-evoked brain potential	24-72 hours	Auditory P300-evoked brain potential: an eventrelated potential of cognitive neurophysiological significance. It represents the brain response to certain sensory/cognitive stimuli by paying attention to the different stimulus among the stereotypical ones (the auditory oddball paradigm). It measures mainly the decision-making process (Polich and Kok, 1995).

Trial Locations

Locations (1)

Mansoura University Hospital; 🇪🇬 Mansoura, Egypt