Temporal Lobe EpilepsyATTENTIONEPIFNCT06466681
Changes in Attentional Control After a Focal Seizure.
An observational study of Temporal Lobe Epilepsy and Frontal Lobe Epilepsy, run by University Hospital, Lille at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Temporal Lobe Epilepsy, Frontal Lobe Epilepsy, Others Subtypes
- What is being tested?
- All included subjects
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 4 Mar 2024to 9 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
University Hospital,
Lille, 59000
Philippe DERAMBURE, Pr, 03 20 44 59 69, philippe.derambure@chu-lille.fr
About this study
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.
- Being tested
- All included subjects
- Keywords
- Attentional control, Focal epilepsy, Event related potentials, Functionnal connectivity, high-resolution EEG
- Medical subject headings
- Epilepsy, Temporal Lobe, Epilepsy, Frontal Lobe, Epilepsies, Partial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
All included subjectsOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Subtest of divided attention of the Test of Attentional Performance (TAP)
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.
Measured: 24 hours
Secondary outcomes (9)
N200 amplitude and latency
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.
Measured: 24 hours
Strength of EEG functionnal connectivity during an attentional task (global and regional)
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.
Measured: 24 hours
Variation of power in several frequency bands (theta, alpha and beta) during an attentional task.
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.
Measured: 24 hours
Magnetic resonance imaging functional connectivity.
Measured: up to 5 days
Differences in N200 and P300 amplitude and latency recorded between different subgroups according to the epileptic focus.
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.
Measured: 24 hours
P300 amplitude and latency
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.
Measured: 24 hours
Differences in strength of EEG functional connectivity during an attentional task recorded between different subgroups according to the epileptic focus.
Measured: 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.
Measured: 24 hours
Differences in magnetic resonance imaging functional connectivity recorded between different subgroups according to the epileptic focus.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start4 Mar 2024
- Primary completion9 Mar 2027 (estimated)
- Study completion9 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporal Lobe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06466681
- Sponsor's protocol ID
- 2022_0762
- Acronym
- ATTENTIONEPIF
- Status last verified
- Apr 2026
- First submitted
- 21 May 2024
- Last updated
- 27 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Attentional Control After a Focal Seizure.
- ClinicalTrials.gov ID
- NCT06466681
- Acronym / sponsor ID
- ATTENTIONEPIF / 2022_0762
- Keywords
- Attentional control, Focal epilepsy, Event related potentials, Functionnal connectivity, high-resolution EEG
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 9 Mar 2027 (estimated)
- Study completion
- 9 Mar 2027 (estimated)
- First posted
- 20 Jun 2024 (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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| All included subjectsAdministration 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. | Other | – |
Primary outcome
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.
9 secondary outcomes
N200 amplitude and latency
Time frame: 24 hours
Strength of EEG functionnal connectivity during an attentional task (global and regional)
Time frame: 24 hours
Variation of power in several frequency bands (theta, alpha and beta) during an attentional task.
Time frame: 24 hours
Magnetic resonance imaging functional connectivity.
Time frame: 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
P300 amplitude and latency
Time frame: 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
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
Differences in magnetic resonance imaging functional connectivity recorded between different subgroups according to the epileptic focus.
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2026.
- Individual participant dataSharing planned: No
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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.
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 Temporal Lobe Epilepsy and Frontal Lobe 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 5 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 27 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subtest of divided attention of the Test of Attentional Performance (TAP) (time frame: 24 hours). 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 27 Apr 2026.