Changes in Attentional Control After a Focal Seizure.

Temporal Lobe Epilepsy Clinical Trial

— ATTENTIONEPIF  

Official title:

Changes in Attentional Control After a Focal Seizure.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06466681
• Other study ID #: 2022_0762
• Status: Recruiting
• Start date: March 4, 2024
• Est. completion date: March 9, 2027

Study information

• Verified date: March 2024
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: March 9, 2027
• Est. primary completion date: March 9, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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 (MoCA = 26)

• 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.

Related Conditions & MeSH terms

• Epilepsy
• Epilepsy, Temporal Lobe
• Seizures
• Temporal Lobe Epilepsy

Intervention

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.

Locations

Country	Name	City	State
France	University Hospital,	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	24 hours
Secondary	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.	24 hours
Secondary	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.	24 hours
Secondary	Magnetic resonance imaging functional connectivity.		up to 5 days
Secondary	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.	24 hours
Secondary	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.	24 hours
Secondary	Differences in strength of EEG functional connectivity during an attentional task recorded between different subgroups according to the epileptic focus.		24 hours
Secondary	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.		24 hours
Secondary	Differences in magnetic resonance imaging functional connectivity recorded between different subgroups according to the epileptic focus.		24 hours