Idiopathic Generalized EpilepsyATTENTIONEPIGNCT05530109
Study of Attentional Disorders in Patients Suffering From Idiopathic Generalized Epilepsy.
An observational study of Idiopathic Generalized Epilepsy, run by University Hospital, Lille at 1 site in France.
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). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Generalized Epilepsy
- What is being tested?
- Neuropsychological screening and high resolution EEG recording
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- 26 Apr 2022to 25 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients from the clinical neurophysiology department of the Lille University Hospital, a reference centre for the follow-up of rare epilepsies.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Idiopathic Generalized Epilepsy
- Being tested
- Neuropsychological screening and high resolution EEG recording
- Keywords
- Attention, Epilepsy, Connectivity, EEG
- Medical subject headings
- Epilepsy, Idiopathic Generalized, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuropsychological screening and high resolution EEG recordingOther
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
| Study group | Role | What they receive |
|---|---|---|
| Patients with idiopathic generalised epilepsy | Not described Receives: Other: Neuropsychological screening and high resolution EEG recording | |
| healthy controls | age- and sex-matched healthy controls Receives: Other: Neuropsychological screening and high resolution EEG recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: At 1 month after inclusion
Secondary outcomes (7)
Raven's progressive matrice scores
cortical source connectivity patterns.
Measured: 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 .
Measured: At 1 month after inclusion
D2-R test score
cortical source connectivity patterns.
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: At 1 month after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start26 Apr 2022
- Primary completion25 Apr 2025
- Study completion25 Apr 2025
Why it stopped: IP's decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Generalized EpilepsyStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe DERAMBURE, MD,PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05530109
- Sponsor's protocol ID
- 2021_0848
- Other IDs
- 2022-A00263-40
- Acronym
- ATTENTIONEPIG
- Status last verified
- May 2025
- First submitted
- 8 Jul 2022
- Last updated
- 15 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Attentional Disorders in Patients Suffering From Idiopathic Generalized Epilepsy.
- ClinicalTrials.gov ID
- NCT05530109
- Acronym / sponsor ID
- ATTENTIONEPIG / 2021_0848
- Conditions
- Idiopathic Generalized Epilepsy
- Keywords
- Attention, Epilepsy, Connectivity, EEG
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: IP's decision
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 26 Apr 2022 (actual)
- Primary completion
- 25 Apr 2025 (actual)
- Study completion
- 25 Apr 2025 (actual)
- First posted
- 7 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with idiopathic generalised epilepsy | – | Other: Neuropsychological screening and high resolution EEG recording |
| healthy controls | – | Other: Neuropsychological screening and high resolution EEG recordingage- and sex-matched healthy controls |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients from the clinical neurophysiology department of the Lille University Hospital, a reference centre for the follow-up of rare epilepsies.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuropsychological screening and high resolution EEG recordingEach 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 | Other | Patients with idiopathic generalised epilepsy, healthy controls |
Primary outcome
Epitrack scale score
Time frame: At 1 month after inclusion
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)
7 secondary outcomes
Raven's progressive matrice scores
Time frame: At 1 month after inclusion
Montreal Cognitive Assessment (MoCA) score
Time frame: At 1 month after inclusion
D2-R test score
Time frame: At 1 month after inclusion
BDI-II score
Time frame: At 1 month after inclusion
STAI scale
Time frame: At 1 month after inclusion
quality of life using the Qolie-31 self questionnaire
Time frame: At 1 month after inclusion
High resolution Electro Encephalo Gram functional connectivity markers at rest and during the ANT task
Time frame: At 1 month after inclusion
Results and safety
The study was stopped early (reason given: IP's decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe DERAMBURE, MD,PhD principal investigator
University Hospital, Lille
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Generalized Epilepsy, run by University Hospital, Lille at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: IP's decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epitrack scale score (time frame: At 1 month after inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2025.