Hepatitis CNCT04389268
P300 in Early Cognitive Impairment in Hepatitis C Virus
An observational study of Hepatitis C and Cognitive Impairment, run by Mansoura University Hospital at 1 site in Egypt.
Trial summary
Approximately 50% of patients with hepatitis C have complaints of fatigue and cognitive deficits even before the development of significant hepatic impairment. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Hepatitis C, Cognitive Impairment
- What is being tested?
- Visual Event-Related Potentials
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2018to 1 Feb 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 100 participants consisted of 50 HCV patients and 50 healthy control, age and sex matched.
Who may be able to join
- Newly diagnosed HCV infection
Who cannot join
- Any neuropsychiatric disease that cause impaired cognition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Predictive Value of P300 Event-related Potential Component in Early Cognitive Impairment in Patients With Uncomplicated Newly Diagnosed Hepatitis C Virus
Approximately 50% of patients with hepatitis C have complaints of fatigue and cognitive deficits even before the development of significant hepatic impairment.
Read the 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.
- Conditions
- Hepatitis C, Cognitive Impairment
- Being tested
- Visual Event-Related Potentials
- Keywords
- Hepatitis C, Cognitive Impairment
- Medical subject headings
- Hepatitis C, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual Event-Related PotentialsDiagnostic 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).
| Study group | Role | What they receive |
|---|---|---|
| HCV patients | Patients with uncomplicated newly diagnosed hepatitis C virus Receives: Diagnostic Test: Visual Event-Related Potentials | |
| Control group | Age and sex matched with patients Receives: Diagnostic Test: Visual Event-Related Potentials |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 24-72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start1 Feb 2018
- Primary completion1 Jan 2019
- Study completion1 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Esmael, Mansoura University Hospital
- Investigators
- Esmael M Ahmed, MD, Principal investigator, Assistant Prof of Neurology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04389268
- Sponsor's protocol ID
- Mansoura University HCV
- Status last verified
- May 2020
- First submitted
- 12 May 2020
- Last updated
- 15 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30804716Louie 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.
PubMed 22494445Barreira 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.
PubMed 30687151Polaris 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.
PubMed 28404132Waked 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.
PubMed 25097045
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of P300 Event-related Potential Component in Early Cognitive Impairment in Patients With Uncomplicated Newly Diagnosed Hepatitis C Virus
- ClinicalTrials.gov ID
- NCT04389268
- Acronym / sponsor ID
- Mansoura University HCV
- Conditions
- Hepatitis C, Cognitive Impairment
- Keywords
- Hepatitis C, Cognitive Impairment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Mansoura University HospitalUniversity, hospital or other
- Study start
- 1 Feb 2018 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Feb 2019 (actual)
- First posted
- 15 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HCV patients | – | Diagnostic Test: Visual Event-Related PotentialsPatients with uncomplicated newly diagnosed hepatitis C virus |
| Control group | – | Diagnostic Test: Visual Event-Related PotentialsAge and sex matched with patients |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 100 participants consisted of 50 HCV patients and 50 healthy control, age and sex matched.
Key inclusion criteria (1 listed)
- Newly diagnosed HCV infection
Key exclusion criteria (1 listed)
- Any neuropsychiatric disease that cause impaired cognition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual Event-Related PotentialsAuditory 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). | Diagnostic test | Control group, HCV patients |
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2020.
- Background: PubMed 30804716Latt 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.
- Background: PubMed 22494445Louie 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.
- Background: PubMed 30687151Barreira 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.
- Background: PubMed 28404132Polaris 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.
- Background: PubMed 25097045Waked 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esmael M Ahmed, MD principal investigator
Assistant Prof of Neurology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C and Cognitive Impairment, run by Mansoura University Hospital at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Auditory P300-evoked brain potential (time frame: 24-72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04389268, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2020.