- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06466681
Changes in Attentional Control After a Focal Seizure. (ATTENTIONEPIF)
April 22, 2026 updated by: University Hospital, Lille
Epilepsy is frequently associated with cognitive and attentional disorders.
Several studies have pointed out that there are modifications of brain activity in resting state during peri-ictal period in EEG and functional MRI.
However, to date, no study has assessed the changes in attentional control after a seizure.
The investigators hypothesize that a localized discharge is associated with a disorganization of the networks engaged in attentional control.
In this regard, the investigators propose a prospective longitudinal study assessing the changes in attentional control after a focal seizure.
Study Overview
Status
Recruiting
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
100
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Lille, France, 59000
- Recruiting
- University Hospital,
-
Contact:
- Philippe DERAMBURE, Pr
- Phone Number: 03 20 44 59 69
- Email: philippe.derambure@chu-lille.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Administration of the subtest of divided attention of the Test of Attentional Performance (TAP), recording of the event related potentiels N200 and P300, measure of the variation of power in several frequency bands (theta, alpha and beta) and measure of the high-resolution EEG connectivity during an attentional task at several time-points : a first time during interictal period (no seizure for more than 24 hours) and 1, 3, 6 and 24 hours after a focal seizure.
Description
Inclusion Criteria:
- Age superior to 18 and under 80
- Focal epilepsy with indication to pre-surgery work-up and 5 days programmed hospitalization dedicated to this work-up
- Normal global cognitive performance (standard progressive Raven matrices score > 5th percentile)
- Be affiliated to the social security system
- Have signed an informed consent
Exclusion Criteria:
- Pregnancy or breastfeeding
- 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)
- Guardianship
- Have a high probability of not respecting the protocol or of abandoning the study
- Absence of any epileptic seizure recorded during the hospitalization
- Recurrent seizures preventing the recording of at least 24 hours without any seizure following a seizure.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Subtest of divided attention of the Test of Attentional Performance (TAP)
Time Frame: 24 hours
|
A first time during interictal period (no seizure for more than 24 hours) (this first measure will be repeated every day until a seizure is recorded) and 1, 3, 6 and 24 hours after a focal seizure.
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
N200 amplitude and latency
Time Frame: 24 hours
|
A first time during interictal period (no seizure for more than 24 hours) (this first measure will be repeated every days until a seizure is recorded) and 1, 3, 6 and 24 hours after a focal seizure.
|
24 hours
|
|
Strength of EEG functionnal connectivity during an attentional task (global and regional)
Time Frame: 24 hours
|
A first time during interictal period (no seizure for more than 24 hours) (this first measure will be repeated every days until a seizure is recorded) and 1, 3, 6 and 24 hours after a focal seizure.
|
24 hours
|
|
Variation of power in several frequency bands (theta, alpha and beta) during an attentional task.
Time Frame: 24 hours
|
A first time during interictal period (no seizure for more than 24 hours) (this first measure will be repeated every day until a seizure is recorded) and 1, 3, 6 and 24 hours after a focal seizure.
|
24 hours
|
|
Magnetic resonance imaging functional connectivity.
Time Frame: up to 5 days
|
up to 5 days
|
|
|
Differences in N200 and P300 amplitude and latency recorded between different subgroups according to the epileptic focus.
Time Frame: 24 hours
|
A first time during interictal period (no seizure for more than 24 hours) (this first measure will be repeated every day until a seizure is recorded) and 1, 3, 6 and 24 hours after a focal seizure.
|
24 hours
|
|
P300 amplitude and latency
Time Frame: 24 hours
|
A first time during interictal period (no seizure for more than 24 hours) (this first measure will be repeated every days until a seizure is recorded) and 1, 3, 6 and 24 hours after a focal seizure.
|
24 hours
|
|
Differences in strength of EEG functional connectivity during an attentional task recorded between different subgroups according to the epileptic focus.
Time Frame: 24 hours
|
24 hours
|
|
|
Differences in variation of power in several frequency bands (theta, alpha and beta) during an attentional task recorded between different subgroups according to the epileptic focus.
Time Frame: 24 hours
|
24 hours
|
|
|
Differences in magnetic resonance imaging functional connectivity recorded between different subgroups according to the epileptic focus.
Time Frame: 24 hours
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 4, 2024
Primary Completion (Estimated)
March 9, 2027
Study Completion (Estimated)
March 9, 2027
Study Registration Dates
First Submitted
May 21, 2024
First Submitted That Met QC Criteria
June 13, 2024
First Posted (Actual)
June 20, 2024
Study Record Updates
Last Update Posted (Actual)
April 27, 2026
Last Update Submitted That Met QC Criteria
April 22, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022_0762
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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