Impact of Interictal Electroencephalographic Abnormalities on the Stability of Attention in the Epilepsies (COGNIT-AIC)
Primary Purpose
Epilepsy
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
abnormal EEGs
Sponsored by
About this trial
This is an interventional diagnostic trial for Epilepsy focused on measuring abnormal EEGs (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)
Sites / Locations
- University Hospital Grenoble
- HCL
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
abnormal EEGs
Arm Description
Outcomes
Primary Outcome Measures
Presence of AIC measured by an EEG on attentional performance
Effect of AIC on attentional fluctuations
Secondary Outcome Measures
Full Information
NCT ID
NCT03094793
First Posted
August 16, 2016
Last Updated
October 17, 2023
Sponsor
University Hospital, Grenoble
Collaborators
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT03094793
Brief Title
Impact of Interictal Electroencephalographic Abnormalities on the Stability of Attention in the Epilepsies
Acronym
COGNIT-AIC
Official Title
Impact of Interictal Electroencephalographic Abnormalities on the Stability of Attention in the Epilepsies in Adults and Children
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
May 2015 (Actual)
Primary Completion Date
May 2019 (Actual)
Study Completion Date
May 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Grenoble
Collaborators
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
Keywords
abnormal EEGs (AIC)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
162 (Actual)
8. Arms, Groups, and Interventions
Arm Title
abnormal EEGs
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
abnormal EEGs
Other Intervention Name(s)
AIC
Intervention Description
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.
Primary Outcome Measure Information:
Title
Presence of AIC measured by an EEG on attentional performance
Description
Effect of AIC on attentional fluctuations
Time Frame
15 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe KAHANE, MD, PUPH
Organizational Affiliation
pkahane@chu-grenoble.fr
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Grenoble
City
Grenoble
ZIP/Postal Code
38100
Country
France
Facility Name
HCL
City
Lyon
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Impact of Interictal Electroencephalographic Abnormalities on the Stability of Attention in the Epilepsies
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