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

NCT03094793 | Completed

• 1 other identifier: 38RC14.374
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 2

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.

Conditions

Epilepsy

Keywords

abnormal EEGs (AIC)

Outcome Measures

Primary Outcomes (1)

• Presence of AIC measured by an EEG on attentional performance

  Effect of AIC on attentional fluctuations

  15 minutes

Study Arms (1)

abnormal EEGs

EXPERIMENTAL

Other: abnormal EEGs

Interventions

abnormal EEGs 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.

Also known as: AIC

abnormal EEGs

Eligibility Criteria

• Age: 6 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Grenoble: lead
• Hospices Civils de Lyon: collaborator

Study Sites (2)

University Hospital Grenoble

Grenoble, 38100, France

Location

HCL

Lyon, France

Location

MeSH Terms

Conditions

Epilepsy; Aicardi Syndrome

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Agenesis of Corpus Callosum; Nervous System Malformations; Eye Diseases, Hereditary; Eye Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Genetic Diseases, X-Linked

Study Officials

• Philippe KAHANE, MD, PUPH

  pkahane@chu-grenoble.fr

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2016
• First Posted: March 29, 2017
• Study Start: May 1, 2015
• Primary Completion: May 1, 2019
• Study Completion: May 1, 2020
• Last Updated: October 18, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)