- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04389268
P300 in Early Cognitive Impairment in Hepatitis C Virus
Predictive Value of P300 Event-related Potential Component in Early Cognitive Impairment in Patients With Uncomplicated Newly Diagnosed Hepatitis C Virus
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Mansoura, Egypt
- Mansoura University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Newly diagnosed HCV infection
Exclusion Criteria:
- Any neuropsychiatric disease that cause impaired cognition
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
HCV patients
Patients with uncomplicated newly diagnosed hepatitis C virus
|
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
|
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).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Auditory P300-evoked brain potential
Time Frame: 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).
|
24-72 hours
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Mental Disorders
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Neurocognitive Disorders
- Liver Diseases
- Flaviviridae Infections
- Hepatitis, Viral, Human
- Enterovirus Infections
- Picornaviridae Infections
- Cognition Disorders
- Hepatitis
- Hepatitis A
- Hepatitis C
- Cognitive Dysfunction
Other Study ID Numbers
- Mansoura University HCV
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hepatitis C
-
Tripep ABInovio PharmaceuticalsUnknownChronic Hepatitis C Virus InfectionSweden
-
Hadassah Medical OrganizationXTL BiopharmaceuticalsWithdrawnChronic Hepatitis C Virus InfectionIsrael
-
Hadassah Medical OrganizationUnknownChronic Hepatitis C Virus InfectionIsrael
-
AbbVieCompletedHepatitis C Virus | Chronic Hepatitis C Virus
-
AbbVie (prior sponsor, Abbott)CompletedHepatitis C | Chronic Hepatitis C Infection | HCV | Hepatitis C Genotype 1United States
-
AbbVieCompletedChronic Hepatitis C | Hepatitis C (HCV) | Hepatitis C Genotype 1a
-
AbbVie (prior sponsor, Abbott)CompletedChronic Hepatitis C | Hepatitis C Genotype 1 | Hepatitis C (HCV)United States, Australia, Canada, France, Germany, New Zealand, Puerto Rico, Spain, United Kingdom
-
Trek Therapeutics, PBCCompletedChronic Hepatitis C | Hepatitis C Genotype 1 | Hepatitis C (HCV) | Hepatitis C Viral InfectionUnited States, New Zealand
-
Trek Therapeutics, PBCCompletedChronic Hepatitis C | Hepatitis C (HCV) | Hepatitis C Genotype 4 | Hepatitis C Viral InfectionUnited States
-
Sohag UniversityRecruiting
Clinical Trials on Visual Event-Related Potentials
-
University of Alabama at BirminghamUniversity of Colorado, Denver; Eunice Kennedy Shriver National Institute of... and other collaboratorsCompletedRett Syndrome, Preserved Speech Variant | Mecp2 Duplication Syndrome | Rett-related DisordersUnited States
-
University Hospital, LimogesUnknown
-
University of Alabama, TuscaloosaUAB Resource Centers for Minority Aging Research (RCMAR)Unknown
-
ERP Biomarker Qualification ConsortiumMerck Sharp & Dohme LLC; Novartis; Takeda; H. Lundbeck A/S; Columbia University; Astellas... and other collaboratorsCompletedSchizophreniaUnited States
-
Centre Hospitalier Universitaire de NiceRecruiting
-
Centre Hospitalier St AnneActive, not recruitingIntractable EpilepsyFrance
-
Tel-Aviv Sourasky Medical CenterUnknown
-
Université Catholique de LouvainRecruitingVisual NeurosciencesBelgium
-
Children's Hospital of PhiladelphiaNational Institute of Neurological Disorders and Stroke (NINDS); Vanderbilt...RecruitingRett Syndrome | Rett Syndrome, Atypical | RTTUnited States