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

Idiopathic Generalized Epilepsy Clinical Trial

— ATTENTIONEPIG  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05530109
• Other study ID #: 2021_0848
• Secondary ID: 2022-A00263-40
• Status: Recruiting
• Start date: April 26, 2022
• Est. completion date: April 2025

Study information

• Verified date: October 2022
• Source: University Hospital, Lille
• Contact: Philippe DERAMBURE, MD,PhD
• Phone: 0320445962
• Email: philippe.derambure[@]chru-lille.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Epilepsy
• Epilepsy, Generalized
• Idiopathic Generalized Epilepsy

Intervention

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

Locations

Country	Name	City	State
France	Hopital Roger Salengro, CHU Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Raven's progressive matrice scores	cortical source connectivity patterns.	At 1 month after inclusion
Secondary	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
Secondary	D2-R test score	cortical source connectivity patterns.	At 1 month after inclusion
Secondary	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
Secondary	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
Secondary	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
Secondary	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