Social Cognition in Pediatric Epilepsy

NCT ID: NCT04253379

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-02
• Study Completion Date: 2027-01-19

Brief Summary

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.

Detailed Description

Epilepsy is a chronic disorder which affects 50 million people all over the world, with a childhood-onset in 75% of cases. This disorder may interfere with the normal cerebral development and impact cognition skills (Bouis, Cavézian et Chokron, 2011 ; Gallagher et Lassonde, 2005). Executive and language functions are often shown to be affected in previous studies with children with epilepsy (Gencpinar et al., 2015 ; Verrotti, Matricardi, Rinaldi, Prezioso et Coppola, 2015). However, executive functioning and language development are known to be implicated in social cognition acquisitions (Carlson et Moses, 2001 ; Smogorzewska, Szumski et Grygiel, 2018). Yet, less is known about social cognition development in people with epilepsy. Social cognition generally refers to mental operations that underlie social interactions, including perceiving, interpreting, managing, and generating responses to socially relevant stimuli, including the intentions and behaviors others.

The purpose of this protocol is to compare development of social cognition skills, language and executive functions in children with and without epilepsy. This is an observational study; volunteers who participate will not receive any new or experimental therapies. Children in this protocol will undergo an evaluation which may include: a medical history including characteristics of their epilepsy (age at onset, number of antiepileptic drugs, seizure frequency, …) , a nonverbal intellectual efficiency measure , an evaluation of theory of mind, key concept of social cognition, and executive functions then an evaluation of verbal skills .The second purpose of this protocol is to permit the identification of links between development of social cognition and executive et language functions.

Children with epilepsy experience more learning disabilities and behavioral disorders. The treatment of pediatric epilepsy concerns seizure reduction but also reeducation therapy to improve scholar outcome, like speech therapy of psychomotricity. Social consequences may be underestimated in this population, including social cognition.

Conditions

Pediatric Epilepsy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

pediatric epilepsy children

Group Type: EXPERIMENTAL

Neuropsychological evaluation , Evaluation of theory of mind, Evaluation of executive functions, Evaluation of verbal skills

Intervention Type: DIAGNOSTIC_TEST

Several 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.

healthy children

Group Type: ACTIVE_COMPARATOR

Neuropsychological evaluation , Evaluation of theory of mind, Evaluation of executive functions, Evaluation of verbal skills

Intervention Type: DIAGNOSTIC_TEST

Several 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.

Interventions

Neuropsychological evaluation , Evaluation of theory of mind, Evaluation of executive functions, Evaluation of verbal skills

Several 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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• neurological or psychiatric disease in control group
• Raven's Matrices score < percentile 10

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 12 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CHU de Reims

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chu Reims

Reims, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Melanie Jennesson Lyver

Role: CONTACT

mjennesson-lyver@chu-reims.fr

3 26 78 78 99 ext. 0033

Facility Contacts

Damien JOLLY

Role: primary

djolly@chu-reims.fr

326788472 ext. 33

Other Identifiers

PO19122*

Identifier Type: -

Identifier Source: org_study_id