Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03094793 |
| Other study ID # |
38RC14.374 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
May 2015 |
| Est. completion date |
May 2020 |
Study information
| Verified date |
October 2023 |
| Source |
University Hospital, Grenoble |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
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.
