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Recruiting NCT06466681

Changes in Attentional Control After a Focal Seizure.

— Observational Temporal Lobe Epilepsy Frontal Lobe Epilepsy Others Subtypes

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: All included subjects.
Who it may be relevant to
Registry conditions: Temporal Lobe Epilepsy, Frontal Lobe Epilepsy, Others Subtypes. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

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.

Interventions

  • Other All included subjects
    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.

Primary outcome measures

  • Subtest of divided attention of the Test of Attentional Performance (TAP) [Time frame: 24 hours]
Secondary outcome measures (9)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • University Hospital, — Lille

Identifiers

NCT: NCT06466681 · 2022_0762

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗