Study of Attentional Disorders in Patients Suffering From Idiopathic Generalized Epilepsy. (ATTENTIONEPIG)

Attentional disorders have been reported in neuropsychological studies evaluating patients suffering from generalized idiopathic epilepsy, but the data are disparate (in terms of test protocol). We aim to describe attentional and executive function disorder in IGE thanks to the Epitrack scale, validated in this specific population. Our secondary objective is to study the dynamic of cortical activity during an attentional task (the ANT), in order to describe the alteration of cortical networks in epileptic patients presenting with attentional disturbance.

Study Overview

• Status: Terminated
• Conditions: Idiopathic Generalized Epilepsy
• Intervention / Treatment: Other: Neuropsychological screening and high resolution EEG recording

• Study Type: Observational
• Enrollment (Actual): 33

Contacts and Locations

Study Locations

• France
  • Lille, France, 59037
    • Hopital Roger Salengro, CHU Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

patients from the clinical neurophysiology department of the Lille University Hospital, a reference centre for the follow-up of rare epilepsies.

Description

Inclusion Criteria:

• Idiopathic generalized epilepsy followed-up during at least 2 years
• At least one antiepileptic drug medication
• No cognitive decline (MoCA score >26)
• Absence of concomitant pathology that could interfere with the purpose of the study.
• Be affiliated to the social security system
• Have signed an informed consent

Exclusion Criteria:

• Pregnancy
• Not able to give consent (Article 1121-8 of the CSP) Vulnerable person Being deprived of liberty by judicial or administrative decision (Article L 1121-6 of the CSP) Have a high probability of not respecting the protocol or of abandoning the study

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with idiopathic generalised epilepsy	Other: Neuropsychological screening and high resolution EEG recording; Each participant will be assessed with a battery of neuropsychological tests including Epitrack, the Raven's progressive matrice, the MoCA, the D2-R test, the BDI-II test, the STAI and the Qolie-31. Then, a prolonged EEG recording at rest and during an attentional task (the ANT) will be realized
healthy controls; age- and sex-matched healthy controls	Other: Neuropsychological screening and high resolution EEG recording; Each participant will be assessed with a battery of neuropsychological tests including Epitrack, the Raven's progressive matrice, the MoCA, the D2-R test, the BDI-II test, the STAI and the Qolie-31. Then, a prolonged EEG recording at rest and during an attentional task (the ANT) will be realized

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Epitrack scale score	EPITrack-Score shows the performance of attention and executive functions. Higher values indicate a better performance. scale from 9-49 (9 worst score - 49 best score)	At 1 month after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Raven's progressive matrice scores	cortical source connectivity patterns.	At 1 month after inclusion
Montreal Cognitive Assessment (MoCA) score	Cognitive function was assessed by using MoCA score. Cognitive impairment was considered present when MoCA scores were <26 .	At 1 month after inclusion
D2-R test score	cortical source connectivity patterns.	At 1 month after inclusion
BDI-II score	Anxiety-depressive symptoms score Beck Depressive Inventory Questionnaire (BDI-II) (score), higher scores mean worse outcome, value minimum of 0 maximum 63	At 1 month after inclusion
STAI scale	Anxiety-depressive symptoms score The State-Trait Anxiety Inventory (STAI) is a self-questionnaire, 20 questions, a score is calculated, ranging from 20 to 80, a high score indicating the presence of anxiety.	At 1 month after inclusion
quality of life using the Qolie-31 self questionnaire	Quality Of Life In Epilepsy-Problems questionnaire (QOLIE31-P) questionnaire has been developed specifically to measure the quality of life of patients with epilepsy. The score ranges from 0 to 100 points. Higher scores reflect better quality of life; lower ones, worse quality of life.	At 1 month after inclusion
High resolution Electro Encephalo Gram functional connectivity markers at rest and during the ANT task	limited number of reproducible resting activity patterns, brain networks involved in the absence of task performance	At 1 month after inclusion

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Philippe DERAMBURE, MD,PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2022
• Primary Completion (Actual): April 25, 2025
• Study Completion (Actual): April 25, 2025

Study Registration Dates

• First Submitted: July 8, 2022
• First Submitted That Met QC Criteria: September 6, 2022
• First Posted (Actual): September 7, 2022

Study Record Updates

• Last Update Posted (Actual): May 15, 2025
• Last Update Submitted That Met QC Criteria: May 12, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: Epilepsy; Attention; EEG; Connectivity
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Epilepsy; Epilepsy, Generalized
• Other Study ID Numbers: 2021_0848; 2022-A00263-40 (Other Identifier: ID-RCB number, ANSM)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No