Clinical trial NCT04389268: P300 in Early Cognitive Impairment in Hepatitis C Virus
Official title: Predictive Value of P300 Event-related Potential Component in Early Cognitive Impairment in Patients With Uncomplicated Newly Diagnosed Hepatitis C Virus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatitis C
Cognitive Impairment
Keywords: Hepatitis C, Cognitive Impairment
Lead sponsor: Mansoura University Hospital
Sponsor class: OTHER
First posted: 2020-05-15
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 100 participants consisted of 50 HCV patients and 50 healthy control, age and sex matched.

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.

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed HCV infection

Exclusion Criteria:

* Any neuropsychiatric disease that cause impaired cognition

Primary outcomes:
measure: Auditory P300-evoked brain potential
timeFrame: 24-72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University Hospital
Study officials:
affiliation: Assistant Prof of Neurology
name: Esmael M Ahmed, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Latt NL. Update on the Management of Hepatitis C Virus Infection in the Setting of Chronic Kidney Disease and Kidney Transplantation. Gastroenterol Hepatol (N Y). 2018 Dec;14(12):687-705.
citation: Louie KS, St Laurent S, Forssen UM, Mundy LM, Pimenta JM. The high comorbidity burden of the hepatitis C virus infected population in the United States. BMC Infect Dis. 2012 Apr 11;12:86. doi: 10.1186/1471-2334-12-86.
citation: Barreira DP, Marinho RT, Bicho M, Fialho R, Ouakinin SRS. Psychosocial and Neurocognitive Factors Associated With Hepatitis C - Implications for Future Health and Wellbeing. Front Psychol. 2019 Jan 9;9:2666. doi: 10.3389/fpsyg.2018.02666. eCollection 2018.
citation: Polaris Observatory HCV Collaborators. Global prevalence and genotype distribution of hepatitis C virus infection in 2015: a modelling study. Lancet Gastroenterol Hepatol. 2017 Mar;2(3):161-176. doi: 10.1016/S2468-1253(16)30181-9. Epub 2016 Dec 16.
citation: Waked I, Doss W, El-Sayed MH, Estes C, Razavi H, Shiha G, Yosry A, Esmat G. The current and future disease burden of chronic hepatitis C virus infection in Egypt. Arab J Gastroenterol. 2014 Jun;15(2):45-52. doi: 10.1016/j.ajg.2014.04.003. Epub 2014 Jun 6. No abstract available.