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TerminatedNCT05530109ATTENTIONEPIGUpdated May 15, 2025

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

An observational study in Idiopathic Generalized Epilepsy, sponsored by University Hospital, Lille. Terminated at 1 site in France. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-15.

Sponsored by University Hospital, Lille · Observational

Why this study was terminated
IP's decision
Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
33
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

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Conditions studied

  • Idiopathic Generalized Epilepsy

Keywords

  • Attention
  • Epilepsy
  • Connectivity
  • EEG
03

In context

Epilepsy, Idiopathic Generalized

35 studies on the registry are indexed under Epilepsy, Idiopathic Generalized; 4 are open to participants now.

Browse Epilepsy, Idiopathic Generalized studies →

Lead sponsor

University Hospital, Lille is the lead sponsor of 631 studies on the registry; 142 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Idiopathic generalized epilepsy followed-up during at least 2 years
  • At least one antiepileptic drug medication
  • No cognitive decline ( 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

Exclusion criteria

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
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

MMSE and MoCA

Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
33 participants (actual)
Patient registry
No

Groups and cohorts

  • 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

  • OtherNeuropsychological 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

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What researchers measure

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)

    Time frame: At 1 month after inclusion

Secondary outcomes

  1. Raven's progressive matrice scores

    cortical source connectivity patterns.

    Time frame: At 1 month after inclusion

  2. Montreal Cognitive Assessment (MoCA) score

    Cognitive function was assessed by using MoCA score. Cognitive impairment was considered present when MoCA scores were \<26 .

    Time frame: At 1 month after inclusion

  3. D2-R test score

    cortical source connectivity patterns.

    Time frame: At 1 month after inclusion

  4. 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

    Time frame: At 1 month after inclusion

  5. 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.

    Time frame: At 1 month after inclusion

  6. 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.

    Time frame: At 1 month after inclusion

  7. 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

    Time frame: At 1 month after inclusion

07

Study locations

1 site
  • Hopital Roger Salengro, CHU Lille
    Lille, 59037, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Apr 2022 to primary completion in Apr 2025, 35 months.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 8, 2022
First posted
Sep 7, 2022
StartActual
Apr 26, 2022
Primary completionActual
Apr 25, 2025
CompletionActual
Apr 25, 2025
Last update
May 15, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 15, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05530109
Responsible party
Sponsor
First posted
Sep 7, 2022
Start date
Apr 26, 2022
Primary completion
Apr 25, 2025
Completion
Apr 25, 2025
Last update
May 15, 2025

Study contacts

Philippe DERAMBURE, MD,PhD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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