NCT06466681

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
10mo left

Started Mar 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress72%
Mar 2024Mar 2027

Study Start

First participant enrolled

March 4, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 21, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 20, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 9, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 9, 2027

Last Updated

April 27, 2026

Status Verified

April 1, 2026

Enrollment Period

3 years

First QC Date

May 21, 2024

Last Update Submit

April 22, 2026

Conditions

Frontal Lobe EpilepsyOthers SubtypesTemporal Lobe Epilepsy

Keywords

Attentional controlFocal epilepsyEvent related potentialsFunctionnal connectivityhigh-resolution EEG

Outcome Measures

Primary Outcomes (1)

  • 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.

    24 hours

Secondary Outcomes (9)

  • N200 amplitude and latency

    24 hours

  • Strength of EEG functionnal connectivity during an attentional task (global and regional)

    24 hours

  • Variation of power in several frequency bands (theta, alpha and beta) during an attentional task.

    24 hours

  • Magnetic resonance imaging functional connectivity.

    up to 5 days

  • Differences in N200 and P300 amplitude and latency recorded between different subgroups according to the epileptic focus.

    24 hours

  • +4 more secondary outcomes

Interventions

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.

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital,

Lille, 59000, France

RECRUITING

MeSH Terms

Conditions

Epilepsy, Temporal LobeEpilepsy, Frontal LobeEpilepsies, Partial

Condition Hierarchy (Ancestors)

EpilepsyBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesEpileptic Syndromes

Study Design

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

Study Record Dates

First Submitted

May 21, 2024

First Posted

June 20, 2024

Study Start

March 4, 2024

Primary Completion (Estimated)

March 9, 2027

Study Completion (Estimated)

March 9, 2027

Last Updated

April 27, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)