- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04376671
Quantitative EEG Markers in Mild Cognitive Impairment in Epilepsy
Study Overview
Detailed Description
Cognitive consequences in epilepsy are often described in the following domains: verbal memory, language, executive functions, and attention. However, most of the studies focus on one or two domains in a relatively small sample.
Few studies have investigated the influential factors for the epilepsy-related cognitive impairment . However, most of these studies merely focused on one or a few potential factors and failed to consider possible distractions from other influential factors. Therefore, it is crucial to include more potential factors in the analysis and to rule out possible confounding interactions between factors.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Mansoura, Egypt
- Mansoura University Hospital
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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:
- Patients with clinically confirmed epilepsy in adult patients.
- Non-symptomatic epilepsy.
- Normal CT or MRI brain, and
- Education level of primary school at least to respond to the scales correctly were included.
Exclusion Criteria:
- Psycho-neurological illnesses,
- History of alcoholism or drug abuse, or
- Recently on medications that may affect cognitive functions (like antidepressants and antipsychotic drugs).
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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temporal lobe epilepsy
Group of patients with temporal lobe epilepsy
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The patients underwent EEG recordings according to previously published methods (Bonanni et al., 2008). .
EEG recordings were analyzed with methods described in our previous work (Bonanni et al., 2008) by 2 experimenters unaware of the clinical conditions of the subjects.
Briefly, quantitative EEGs (QEEGs) were recorded from 21 scalp derivations.
Ag/AgCl disk scalp electrodes (19) were placed according to the international 10-20 system, EEG was recorded from Fp1, Fp2, Fz, F3, F4, F7, F8, Cz, C3, C4, Pz, P3, P4, T3, T 4, T5, T6, O1, and O2.
Two additional electrodes were placed on A1 and A2.
EEG activity was analyzed from single or multiple leads grouped to define the following scalp regions: anterior (Fz, Fp2, F7, Fp1, F3, F4, and F8), central (Cz, C3, and C4), posterior (Pz, P3, P4, O1, and O2), and temporal (T3, T4, T5, and T6).
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Extra-temporal lobe epilepsy
Group of patients with extra-temporal lobe epilepsy
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The patients underwent EEG recordings according to previously published methods (Bonanni et al., 2008). .
EEG recordings were analyzed with methods described in our previous work (Bonanni et al., 2008) by 2 experimenters unaware of the clinical conditions of the subjects.
Briefly, quantitative EEGs (QEEGs) were recorded from 21 scalp derivations.
Ag/AgCl disk scalp electrodes (19) were placed according to the international 10-20 system, EEG was recorded from Fp1, Fp2, Fz, F3, F4, F7, F8, Cz, C3, C4, Pz, P3, P4, T3, T 4, T5, T6, O1, and O2.
Two additional electrodes were placed on A1 and A2.
EEG activity was analyzed from single or multiple leads grouped to define the following scalp regions: anterior (Fz, Fp2, F7, Fp1, F3, F4, and F8), central (Cz, C3, and C4), posterior (Pz, P3, P4, O1, and O2), and temporal (T3, T4, T5, and T6).
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Mini-mental state examination (MMSE)
Time Frame: 24 hours
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This is a rapid screening tool to estimate the cognitive functions that evaluates orientation, basic attention, working memory, learning, naming, construction, comprehension, and repetition.
The maximum score is 30 and scores below 24 indicating cognitive impairment.
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24 hours
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Montreal cognitive assessment (MoCA)
Time Frame: 24 hours
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Montreal cognitive assessment is a rapid sensitive screening tool for assessment of impaired cognitive function (Nasreddine et al., 2005).
The main domains of MoCA scale include attention, executive functions, memory, language, attention, naming, orientation, and visual-spatial ability.
The total score is 30 points.
A score of 25 points or less indicated impaired cognitive function.
For patients with less than12 years of education, one point was added to the total score.
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24 hours
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- England MJ, Liverman CT, Schultz AM, Strawbridge LM. Epilepsy across the spectrum: promoting health and understanding. A summary of the Institute of Medicine report. Epilepsy Behav. 2012 Oct;25(2):266-76. doi: 10.1016/j.yebeh.2012.06.016. Epub 2012 Oct 5.
- Matonda-Ma-Nzuzi T, Mampunza Ma Miezi S, Mpembi MN, Mvumbi DM, Aloni MN, Malendakana F, Mpaka Mbeya D, Lelo GM, Charlier-Mikolajczak D. Factors associated with behavioral problems and cognitive impairment in children with epilepsy of Kinshasa, Democratic Republic of the Congo. Epilepsy Behav. 2018 Jan;78:78-83. doi: 10.1016/j.yebeh.2017.08.030. Epub 2017 Nov 25.
- Bora E, Meletti S. Social cognition in temporal lobe epilepsy: A systematic review and meta-analysis. Epilepsy Behav. 2016 Jul;60:50-57. doi: 10.1016/j.yebeh.2016.04.024. Epub 2016 May 11.
- Black LC, Schefft BK, Howe SR, Szaflarski JP, Yeh HS, Privitera MD. The effect of seizures on working memory and executive functioning performance. Epilepsy Behav. 2010 Mar;17(3):412-9. doi: 10.1016/j.yebeh.2010.01.006. Epub 2010 Feb 13.
- Cassel A, Morris R, Koutroumanidis M, Kopelman M. Forgetting in temporal lobe epilepsy: When does it become accelerated? Cortex. 2016 May;78:70-84. doi: 10.1016/j.cortex.2016.02.005. Epub 2016 Feb 24.
- Bonanni L, Thomas A, Tiraboschi P, Perfetti B, Varanese S, Onofrj M. EEG comparisons in early Alzheimer's disease, dementia with Lewy bodies and Parkinson's disease with dementia patients with a 2-year follow-up. Brain. 2008 Mar;131(Pt 3):690-705. doi: 10.1093/brain/awm322. Epub 2008 Jan 17.
- Elsherif M, Esmael A. Hippocampal atrophy and quantitative EEG markers in mild cognitive impairment in temporal lobe epilepsy versus extra-temporal lobe epilepsy. Neurol Sci. 2022 Mar;43(3):1975-1986. doi: 10.1007/s10072-021-05540-4. Epub 2021 Aug 18.
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- Mansoura University 15
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
product manufactured in and exported from the U.S.
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.
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