NCT05530109

Brief 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.

Trial Health

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Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2022

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 26, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 7, 2022

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 25, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 25, 2025

Completed
Last Updated

May 15, 2025

Status Verified

May 1, 2025

Enrollment Period

3 years

First QC Date

July 8, 2022

Last Update Submit

May 12, 2025

Conditions

Keywords

AttentionEpilepsyConnectivityEEG

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Raven's progressive matrice scores

    At 1 month after inclusion

  • Montreal Cognitive Assessment (MoCA) score

    At 1 month after inclusion

  • D2-R test score

    At 1 month after inclusion

  • BDI-II score

    At 1 month after inclusion

  • STAI scale

    At 1 month after inclusion

  • +2 more secondary outcomes

Study Arms (2)

Patients with idiopathic generalised epilepsy

Other: Neuropsychological screening and high resolution EEG recording

healthy controls

age- and sex-matched healthy controls

Other: Neuropsychological screening and high resolution EEG recording

Interventions

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

Patients with idiopathic generalised epilepsyhealthy controls

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Roger Salengro, CHU Lille

Lille, 59037, France

Location

MeSH Terms

Conditions

Epilepsy, Idiopathic GeneralizedEpilepsy

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Philippe DERAMBURE, MD,PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 8, 2022

First Posted

September 7, 2022

Study Start

April 26, 2022

Primary Completion

April 25, 2025

Study Completion

April 25, 2025

Last Updated

May 15, 2025

Record last verified: 2025-05

Locations