Social Cognition in Pediatric Epilepsy (TOMEPI)
Primary Purpose
Pediatric Epilepsy
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Neuropsychological evaluation , Evaluation of theory of mind, Evaluation of executive functions, Evaluation of verbal skills
Sponsored by
About this trial
This is an interventional basic science trial for Pediatric Epilepsy
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
Sites / Locations
- Chu ReimsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
pediatric epilepsy children
healthy children
Arm Description
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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)
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04253379
Brief Title
Social Cognition in Pediatric Epilepsy
Acronym
TOMEPI
Official Title
Impact of Executive Functions and Language on Social Cognition in Pediatric Epilepsy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 2, 2020 (Actual)
Primary Completion Date
October 19, 2024 (Anticipated)
Study Completion Date
January 19, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pediatric Epilepsy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
96 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
pediatric epilepsy children
Arm Type
Experimental
Arm Title
healthy children
Arm Type
Active Comparator
Intervention Type
Diagnostic Test
Intervention Name(s)
Neuropsychological evaluation , Evaluation of theory of mind, Evaluation of executive functions, Evaluation of verbal skills
Intervention Description
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.
Primary Outcome Measure Information:
Title
Social cognition evaluation
Description
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 0
Secondary Outcome Measure Information:
Title
Non verbal intellectual efficiency
Description
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 0
Title
Executive functions evaluation
Description
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 0
Title
language evaluation
Description
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 0
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Melanie Jennesson Lyver
Phone
3 26 78 78 99
Ext
0033
Email
mjennesson-lyver@chu-reims.fr
Facility Information:
Facility Name
Chu Reims
City
Reims
ZIP/Postal Code
51092
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Damien JOLLY
Phone
326788472
Ext
33
Email
djolly@chu-reims.fr
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Social Cognition in Pediatric Epilepsy
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