Social Cognition in Pediatric Epilepsy
ConditionPediatric Epilepsy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorCHU de Reims
About this trial
The purpose of this study is to investigate the development of social cognition skills in pediatric epilepsy compared to healthy children. There are evidences indicating that children with epilepsy have executive dysfunctions and language problems. Executive functions refer to multiple cognitive processes that contribute to human higher order abilities, such as purposeful and future-orientated behavior. Moreover, the literature regarding development of non epileptic children, with ordinary development indicates that executive functions and language are linked to the emergence of social cognition. Then, the investigators asked if children with epilepsy, as they commonly present executive dysfunctions, would show an atypical development of social cognition. Children with epilepsy and a control group of healthy volunteers will be compared to identify relationships between executive functions, language and social cognition.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
exposed children : children aged 6-12 with a diagnosis of epilepsy French native speaker
A control group of age-matched children who meet patient selection criteria with the exception of the epilepsy will also be sought
Disqualifiers
neurological or psychiatric disease in control group
Raven's Matrices score < percentile 10
Trial design
Design model
Parallel
Treatments tested in this trial
Neuropsychological evaluation , Evaluation of theory of mind, Evaluation of executive functions, Evaluation of verbal skills
Diagnostic testSeveral tests will be used: Raven's Advanced Progressive Matrices, auditory attention subtest of the NEPSY II, Peabody Picture Vocabulary test, specific comprehension test The cognitive TOM will be evaluated with questions about 4 stories of false beliefs. The affective TOM will be evaluated with a specific emotion inference task 4 adapted subtests from several validated scales will be used to investigate inhibition, cognitive flexibility and working memory The semantic and pragmatic competences will be evaluated with 4 comprehension tasks.
Treatment groups
96 Participants
are divided into 2 treatment groupsGroup A: pediatric epilepsy childrenExperimental treatment 1 intervention
Group B: healthy childrenActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Social cognition evaluation
The cognitive theory of mind test The Cognitive Theory of mind will be evaluated with questions about 4 small stories of false beliefs. Number of items : 8 questions Minimum and Maximum values : 0-8 correct responses
Time frame
Day 0Secondary outcomes
1
Non verbal intellectual efficiency
Raven's Advanced Progressive Matrices It consists of 36 visual geometric designs with a missing piece. In each matrix, the child will select the piece that best completes the pattern. Number of items : 36 Minimum and maximum values : 0 - 36 correct responses
Time frame
Day 02
Executive functions evaluation
Adaptation of the Flanker Task Executive functions will be evaluated with computized task. For each trial, the child will identify the direction of the central fish. The flanking fish will be pointing in the same direction as the central fish (congruent condition) or in the opposite direction (incongruent condition). Number of items : 36 items per condition Minimum and Maximum values : 0 - 1700 millisecondes (Means of Reaction Time)
Time frame
Day 03
language evaluation
Peabody Picture Vocabulary Test : In each trial, the child will point one picture out of four, the one that best matches a word given by the examiner Number of items : 170 Minimum and Maximum values : 0-170 correct responses
Time frame
Day 0Sponsors and contacts
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Source ClinicalTrials.gov