NCT03688516

Brief Summary

It's well established in the literature that emotional events are more likely to be remembered than neutral events. Although this Emotional Enhancement of Memory (EEM) has been well demonstrated in the adult literature, little is known about EEM for typically developing children and children with Williams-Beuren syndrome (WBS). In this study, two investigations will be conducted concomitantly: one of EEM in typically developing children and the other of EEM in children with WBS. For this purpose, three behavioral experiments will be established to investigate EEM in this two populations, with the first experiment also including electroencephalography measures. Performances of typically developing children will be compared to young adults, and performances of children with WBS will be compared to control children matched for mental age. Finally, this study aims to bring new knowledge about the interactions between emotion and memory in children, and to better understand cognitive functioning in children with WBS.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 28, 2018

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

July 2, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

September 28, 2018

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2020

Completed
Last Updated

February 9, 2021

Status Verified

February 1, 2021

Enrollment Period

2.5 years

First QC Date

July 2, 2018

Last Update Submit

February 8, 2021

Conditions

Keywords

emotionmemoryWilliams-Beuren syndrome

Outcome Measures

Primary Outcomes (1)

  • Manipulation of Valence

    Behavioral measure:number of correct responses (correct recall and correct recognition), evoked potential for EEG only for Experiment 1

    During the presentation of the stimuli or just after the presentation of the stimuli

Secondary Outcomes (6)

  • EEG measures

    During the presentation of the stimuli or just after the presentation of the stimuli

  • Source memory

    During the presentation of the stimuli or just after the presentation of the stimuli

  • Content memory

    During the presentation of the stimuli or just after the presentation of the stimuli

  • Spatial memory

    During the presentation of the stimuli or just after the presentation of the stimuli

  • Recognition memory

    During the presentation of the stimuli or just after the presentation of the stimuli

  • +1 more secondary outcomes

Study Arms (2)

Atypical development

EXPERIMENTAL

30 children with Williams-Beuren syndrome will be presented with two tasks of episodic memory, one with visual stimuli and another one with audio-verbal stimuli. Manipulation of valence and modality (negative, positive, neutral) in order to measure influence of emotion on episodic memory:Spatial and recognition memory ans source and content memory. The tasks will be presented one after another with a break of 15 minutes. In both tasks the participants will have to encode the stimuli and then first recall them and second to recognize the encoded stimuli amongst new stimuli. The stimuli will be presented on the computer. The responses will be collected by the experimenter for recall task and by the computer for recognition task. During the recognition task the EEG recording will be done.

Behavioral: Manipulation of valence and modalityBehavioral: Spatial and recognition memoryBehavioral: Source and content memory

Typical development

SHAM COMPARATOR

30 control children matched for mental age will be presented with two tasks of episodic memory, one with visual stimuli and another one with audio-verbal stimuli. Manipulation of valence and modality (negative, positive, neutral) in order to measure influence of emotion on episodic memory:Spatial and recognition memory ans source and content memory. The tasks will be presented one after another with a break of 15 minutes. In both tasks the participants will have to encode the stimuli and then first recall them and second to recognize the encoded stimuli amongst new stimuli. The stimuli will be presented on the computer. The responses will be collected by the experimenter for recall task and by the computer for recognition task. During the recognition task the EEG recording will be done.

Behavioral: Manipulation of valence and modalityBehavioral: Spatial and recognition memoryBehavioral: Source and content memory

Interventions

mnemic task with a phase of encoding negative, positive and neutral stimuli, will be proposed followed by an immediate recovery phase, composed of a recall task followed by a recognition task

Atypical developmentTypical development

mnemic task with a phase of encoding negative, positive and neutral stimuli, will be proposed followed by an immediate recovery phase, composed of a recall task followed by a recognition task

Atypical developmentTypical development

mnemic task with a phase of encoding negative, positive and neutral stimuli, will be proposed followed by an immediate recovery phase, composed of a recall task followed by a recognition task

Atypical developmentTypical development

Eligibility Criteria

Age6 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Children with William-Beuren syndrome
  • Genetic diagnosis (CGH-Array or FISH) of microdeletion 7q11.23
  • to 18 years old
  • Native French speaker
  • Typically developing children and healthy adults:
  • to 30 years old
  • Native French speaker
  • Absence of history of neurodevelopmental neurological and psychiatric disease

You may not qualify if:

  • Children with William-Beuren syndrome:
  • Diagnosis of severe intellectual deficit (Total IQ lower than 40 evaluated with WPPSI-II or WISC-IV)
  • Presence of another genetic anomaly
  • Presence of vascular; infectious or neurodegenerative disease
  • Medication impacting motor and cognitive abilities
  • Non-corrected visual and hearing impairment
  • Typically developing children and Healthy Adults :
  • Diagnosis of severe intellectual deficit (Total IQ lower than 70 evaluated with WPPSI-II or WISC-IV)
  • Presence of vascular; infectious or neurodegenerative disease knew by parents or legal representative
  • Learning disorders
  • History of neurological or psychiatric disease
  • Medication impacting motor and cognitive abilities, non-corrected visual and hearing impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hopital Vinatier

Lyon, Auvergne-Rhône-Alpes, 69678, France

Location

MeSH Terms

Conditions

Mental DisordersWilliams Syndrome

Condition Hierarchy (Ancestors)

Intellectual DisabilityNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesAortic Stenosis, SupravalvularAortic Valve StenosisAortic Valve DiseaseHeart Valve DiseasesHeart DiseasesCardiovascular DiseasesChromosome DisordersCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, Inborn

Study Officials

  • DEMILY CAROLINE

    CH LE VINATIER

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2018

First Posted

September 28, 2018

Study Start

June 28, 2018

Primary Completion

December 15, 2020

Study Completion

December 15, 2020

Last Updated

February 9, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations