Impact of Interictal Electroencephalographic Abnormalities on the Stability of Attention in the Epilepsies

NCT ID: NCT03094793

Last Updated: 2023-10-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 162 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2020-05-31

Brief Summary

Cognitive disorders are a major problem in patients with epilepsy. One hypothesis is that the anomalies EEGs (AIC) may be responsible for short periods of attentional fluctuations causing a reduction of intellectual efficiency of patients. In this project, we propose to evaluate the impact of AIC on cognitive performance, specifically on attentional performance (central parameter of cognitive functioning) through the use of a computerized cognitive test (called STABILO, detailed below after) to measure, with good temporal sampling, the level of attentional engagement of patients in relation to their EEG activity.

The originality of this study lies in the synchronization of two examinations usually made independently (EEG and psychometric testing), respecting a precise temporal coupling. The aim is to provide clinicians with a tool to assess very quickly attentional fluctuations in epileptic patients, and to assess the potential impact of AIC on the occurrence of these changes, with possible therapeutic implications (treatment of AIC and / or specific treatment of attention deficit disorder).

The main objective of this study is to assess whether the presence of AIC EEG can induce a weakening of attentional performance.

Detailed Description

Cognitive disorders are a major problem in patients with epilepsy. A hypothesis supported by several authors postulated that abnormal EEGs (AIC) may be responsible for short periods of attentional fluctuations causing a reduction of intellectual efficiency of patients. Indeed, attention is a central parameter of human cognition, conditioning performance and welfare in virtually all areas of activity.

In this project, we propose to evaluate the impact of AIC on cognitive performance, specifically on attentional performance (central parameter of cognitive functioning) through the use of a computerized cognitive test (called STABILO, detailed below after) to measure, with good temporal sampling, the level of attentional engagement of patients in relation to their EEG activity.

The originality of this study lies in the synchronization of two examinations usually made independently (EEG and psychometric testing), respecting a precise temporal coupling. The aim is to provide clinicians with a tool to assess very quickly attentional fluctuations in epileptic patients, and to assess the potential impact of AIC on the occurrence of these changes, with possible therapeutic implications (treatment of AIC and / or specific treatment of attention deficit disorder).

This study consists in a scalp EEG to detect, in real time, based on measurements of reaction time and accuracy of responses (recorded every two seconds), the level of attention given by the participant in a repetitive task of constant difficulty and correlate the behavioral results to AIC identified on the EEG recording. A computer equipped for the realization of the STABILO test is already available, its connection / synchronization with standard acquisition systems EEG data is already effective through an RS232 serial port.

Included patients will see their EEG extended for fifteen minutes, during which they will carry out a computerized attention task (This is the STABILO experimental protocol developed by JP Lachaux and V. Herbillon) allowing the evaluation of the stability of 'attention.

Conditions

Epilepsy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

abnormal EEGs

Group Type: EXPERIMENTAL

abnormal EEGs

Intervention Type: OTHER

This study consists in a scalp EEG to detect, in real time, based on measurements of reaction time and accuracy of responses (recorded every two seconds), the level of attention given by the participant in a repetitive task of constant difficulty and correlate the behavioral results to AIC identified on the EEG recording. A computer equipped for the realization of the STABILO test is already available, its connection / synchronization with standard acquisition systems EEG data is already effective through an RS232 serial port.

Included patients will see their EEG extended for fifteen minutes, during which they will carry out a computerized attentional task to evaluate the stability of the attention.

Interventions

abnormal EEGs

This study consists in a scalp EEG to detect, in real time, based on measurements of reaction time and accuracy of responses (recorded every two seconds), the level of attention given by the participant in a repetitive task of constant difficulty and correlate the behavioral results to AIC identified on the EEG recording. A computer equipped for the realization of the STABILO test is already available, its connection / synchronization with standard acquisition systems EEG data is already effective through an RS232 serial port.

Included patients will see their EEG extended for fifteen minutes, during which they will carry out a computerized attentional task to evaluate the stability of the attention.

Intervention Type: OTHER

Other Intervention Names

AIC

Eligibility Criteria

Inclusion Criteria

• Patient major or minor age 6 to 65 (L1121-7 CSP)
• Written agreement of participation in the study patient and his legal representative
• Epilepsy proved, during diagnosis, or TDA justifying the realization of an EEG or video-EEG monitoring

Exclusion Criteria

• Patient deprived of liberty by a judicial or administrative decision (L1121-6 CSP)
• Major Patients undergoing a legal protection measure or unable to consent (L1121-8 CSP)
• Pregnant or lactating women (L1121-5 CSP)
• Handicap making it impossible to complete the test (severe intellectual disability, severe motor deficit of the upper limbs, blindness)

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: collaborator

University Hospital, Grenoble

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Philippe KAHANE, MD, PUPH

Role: PRINCIPAL_INVESTIGATOR

pkahane@chu-grenoble.fr

Locations

University Hospital Grenoble

Grenoble, , France

HCL

Lyon, , France

Countries

France

Other Identifiers

38RC14.374

Identifier Type: -

Identifier Source: org_study_id