EpilepsyNCT04376671
Quantitative EEG Markers in Mild Cognitive Impairment in Epilepsy
An observational study of Epilepsy, run by Mansoura University Hospital at 1 site in Egypt.
Trial summary
Epileptic patients are plighted with limited daily activities, social dysfunction, family conflicts and cognitive impairment. Most of the studies had showed that cognitive disorders were frequent in patients with epilepsy.The cognitive impairment has been reported in around 25% of epileptic patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Epilepsy
- What is being tested?
- Electroencephalography
- Type of treatment
- Medical device
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2019to 1 Mar 2020
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: A total of 90 adult epileptic patients (according to the diagnosis of epilepsy in 2017, Fisher et al., 2017), 50 males and 40 females. With average age 24.5 ±5 .63.
Who may be able to join
- 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.
Who cannot join
- Psycho-neurological illnesses,
- History of alcoholism or drug abuse, or
- Recently on medications that may affect cognitive functions (like antidepressants and antipsychotic drugs).
Trial locations and contacts
1 site in 1 country.
About this study
Epileptic patients are plighted with limited daily activities, social dysfunction, family conflicts and cognitive impairment. Most of the studies had showed that cognitive disorders were frequent in patients with epilepsy.The cognitive impairment has been reported in around 25% of epileptic patients.
Read the 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.
- Conditions
- Epilepsy
- Being tested
- Electroencephalography
- Keywords
- Epilepsy, Mini Mental State Examination
- Medical subject headings
- Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroencephalographyDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| temporal lobe epilepsy | Group of patients with temporal lobe epilepsy Receives: Device: Electroencephalography | |
| Extra-temporal lobe epilepsy | Group of patients with extra-temporal lobe epilepsy Receives: Device: Electroencephalography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mini-mental state examination (MMSE)
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.
Measured: 24 hours
Montreal cognitive assessment (MoCA)
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.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2020
- Study start1 Mar 2019
- Primary completion1 Feb 2020
- Study completion1 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for EpilepsyStudies 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 only
- Time perspective
- Retrospective
- Enrolment
- 90 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
- NCT04376671
- Sponsor's protocol ID
- Mansoura University 15
- Status last verified
- May 2020
- First submitted
- 3 May 2020
- Last updated
- 6 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 23041175Matonda-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.
PubMed 29179103Bora 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.
PubMed 27179192Black 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.
PubMed 20153981Cassel 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.
PubMed 27010834Bonanni 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.
PubMed 18202105Elsherif 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.
PubMed 34406537
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantitative EEG Markers in Mild Cognitive Impairment in Epilepsy
- ClinicalTrials.gov ID
- NCT04376671
- Acronym / sponsor ID
- Mansoura University 15
- Conditions
- Epilepsy
- Keywords
- Epilepsy, Mini Mental State Examination
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Mansoura University HospitalUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- 1 Feb 2020 (actual)
- Study completion
- 1 Mar 2020 (actual)
- First posted
- 6 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.
Epileptic patients are plighted with limited daily activities, social dysfunction, family conflicts and cognitive impairment. Most of the studies had showed that cognitive disorders were frequent in patients with epilepsy.The cognitive impairment has been reported in around 25% of epileptic patients.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| temporal lobe epilepsy | – | Device: ElectroencephalographyGroup of patients with temporal lobe epilepsy |
| Extra-temporal lobe epilepsy | – | Device: ElectroencephalographyGroup of patients with extra-temporal lobe epilepsy |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A total of 90 adult epileptic patients (according to the diagnosis of epilepsy in 2017, Fisher et al., 2017), 50 males and 40 females. With average age 24.5 ±5 .63.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Psycho-neurological illnesses,
- History of alcoholism or drug abuse, or
- Recently on medications that may affect cognitive functions (like antidepressants and antipsychotic drugs).
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 |
|---|---|---|
| ElectroencephalographyThe 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). | Device | Extra-temporal lobe epilepsy, temporal lobe epilepsy |
Primary outcome
Mini-mental state examination (MMSE)
Time frame: 24 hours
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.
Montreal cognitive assessment (MoCA)
Time frame: 24 hours
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.
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 6 May 2020.
- Background: PubMed 23041175England 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.
- Background: PubMed 29179103Matonda-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.
- Background: PubMed 27179192Bora 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.
- Background: PubMed 20153981Black 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.
- Background: PubMed 27010834Cassel 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.
- Background: PubMed 18202105Bonanni 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.
- Derived from this study: PubMed 34406537Elsherif 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.
- 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 Epilepsy, 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 4 inclusion and 3 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 6 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?
Mini-mental state examination (MMSE) (time frame: 24 hours). The study lists 2 primary outcomes in all. 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 NCT04376671, which also lists 7 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 6 May 2020.