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

Impact of Interictal Electroencephalographic Abnormalities on the Stability of Attention in the Epilepsies in Adults and Children

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03094793
Acronym
COGNIT-AIC
Enrollment
162
Registered
2017-03-29
Start date
2015-05-31
Completion date
2020-05-31
Last updated
2023-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Keywords

abnormal EEGs (AIC)

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.

Interventions

OTHERabnormal 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.

Sponsors

Hospices Civils de Lyon
CollaboratorOTHER
University Hospital, Grenoble
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
6 Years to 65 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Presence of AIC measured by an EEG on attentional performance15 minutesEffect of AIC on attentional fluctuations

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026