NCT04376671

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2019

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2020

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 6, 2020

Completed
Last Updated

May 6, 2020

Status Verified

May 1, 2020

Enrollment Period

11 months

First QC Date

May 3, 2020

Last Update Submit

May 3, 2020

Conditions

Keywords

Epilepsy, Mini Mental State Examination

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    24 hours

Study Arms (2)

temporal lobe epilepsy

Group of patients with temporal lobe epilepsy

Device: Electroencephalography

Extra-temporal lobe epilepsy

Group of patients with extra-temporal lobe epilepsy

Device: Electroencephalography

Interventions

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).

Extra-temporal lobe epilepsytemporal lobe epilepsy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • Psycho-neurological illnesses,
  • History of alcoholism or drug abuse, or
  • Recently on medications that may affect cognitive functions (like antidepressants and antipsychotic drugs).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mansoura University Hospital

Al Mansurah, Egypt

Location

Related Publications (7)

  • 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.

    PMID: 23041175BACKGROUND
  • 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.

    PMID: 29179103BACKGROUND
  • 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.

    PMID: 27179192BACKGROUND
  • 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.

    PMID: 20153981BACKGROUND
  • 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.

    PMID: 27010834BACKGROUND
  • 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.

    PMID: 18202105BACKGROUND
  • 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.

MeSH Terms

Conditions

Epilepsy

Interventions

Electroencephalography

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, NeurologicalDiagnostic Techniques and ProceduresDiagnosisElectrodiagnosis

Study Officials

  • Esmael M Ahmed, MD

    Assistant Prof of Neurology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Prof of Neurology

Study Record Dates

First Submitted

May 3, 2020

First Posted

May 6, 2020

Study Start

March 1, 2019

Primary Completion

February 1, 2020

Study Completion

March 1, 2020

Last Updated

May 6, 2020

Record last verified: 2020-05

Data Sharing

IPD Sharing
Will not share

Locations