P300 in Early Cognitive Impairment in Hepatitis C Virus

NCT ID: NCT04389268

Last Updated: 2020-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-01

Study Completion Date

2019-02-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Hepatitis C Cognitive Impairment

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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HCV patients

Patients with uncomplicated newly diagnosed hepatitis C virus

Visual Event-Related Potentials

Intervention Type DIAGNOSTIC_TEST

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).

Control group

Age and sex matched with patients

Visual Event-Related Potentials

Intervention Type DIAGNOSTIC_TEST

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).

Interventions

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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).

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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Inclusion Criteria

* Newly diagnosed HCV infection

Exclusion Criteria

* Any neuropsychiatric disease that cause impaired cognition
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mansoura University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Esmael

Assistant Prof of Neurology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Esmael M Ahmed, MD

Role: PRINCIPAL_INVESTIGATOR

Assistant Prof of Neurology

Locations

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Mansoura University Hospital

Al Mansurah, , Egypt

Site Status

Countries

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Egypt

References

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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.

Reference Type BACKGROUND
PMID: 30804716 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22494445 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30687151 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28404132 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25097045 (View on PubMed)

Other Identifiers

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Mansoura University HCV

Identifier Type: -

Identifier Source: org_study_id

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