P300 in Early Cognitive Impairment in Hepatitis C Virus

Hepatitis C Clinical Trial

Official title:

Predictive Value of P300 Event-related Potential Component in Early Cognitive Impairment in Patients With Uncomplicated Newly Diagnosed Hepatitis C Virus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04389268
• Other study ID #: Mansoura University HCV
• Status: Completed
• Start date: February 1, 2018
• Est. completion date: February 1, 2019

Study information

• Verified date: May 2020
• Source: Mansoura University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 1, 2019
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Newly diagnosed HCV infection

Exclusion Criteria:

• Any neuropsychiatric disease that cause impaired cognition

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Hepatitis
• Hepatitis A
• Hepatitis C

Intervention

Diagnostic Test:
• Visual Event-Related Potentials
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).

Locations

Country	Name	City	State
Egypt	Mansoura University Hospital	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University Hospital

Country where clinical trial is conducted

Egypt, 

References & Publications (5)

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. Review. — View 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. — View 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. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Auditory P300-evoked brain potential	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).	24-72 hours