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- Ensayo clínico NCT04376671
Quantitative EEG Markers in Mild Cognitive Impairment in Epilepsy
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Mansoura, Egipto
- Mansoura University Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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).
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Solo caso
- Perspectivas temporales: Retrospectivo
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Mini-mental state examination (MMSE)
Periodo de tiempo: 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)
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- Mansoura University 15
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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