Social Cognition in Pediatric Epilepsy

NCT04253379 | Recruiting DMC

• 1 other identifier: PO19122*
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 1

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.

Conditions

Pediatric Epilepsy

Outcome Measures

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

  Day 0

Secondary Outcomes (3)

• Non verbal intellectual efficiency

  Day 0

• Executive functions evaluation

  Day 0

• language evaluation

  Day 0

Study Arms (2)

pediatric epilepsy children

EXPERIMENTAL

Diagnostic Test: Neuropsychological evaluation , Evaluation of theory of mind, Evaluation of executive functions, Evaluation of verbal skills

healthy children

ACTIVE COMPARATOR

Diagnostic Test: Neuropsychological evaluation , Evaluation of theory of mind, Evaluation of executive functions, Evaluation of verbal skills

Interventions

Neuropsychological evaluation , Evaluation of theory of mind, Evaluation of executive functions, Evaluation of verbal skills 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; pediatric epilepsy children

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• CHU de Reims: lead

Study Sites (1)

Chu Reims

Reims, 51092, France

RECRUITING

Central Study Contacts

Melanie Jennesson Lyver

CONTACT

3 26 78 78 99; mjennesson-lyver@chu-reims.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2020
• First Posted: February 5, 2020
• Study Start: February 2, 2020
• Primary Completion (Estimated): October 19, 2026
• Study Completion (Estimated): January 19, 2027
• Last Updated: September 22, 2025

Record last verified: 2025-09

Locations

FR (1)