- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03688516
Effects of Emotion on Episodic Memory in Typically Developing Children and Children With Williams-Beuren Syndrome (EEM-TAdev)
Study Overview
Status
Conditions
Detailed Description
The main objective of the present project is to characterize the emotional modulation of episodic memory in typically developing (TD) children and children with Williams-Beuren syndrome (WBS), by using behavioral and encephalography (EEG) measures. Better understanding of interaction between cognition and emotion in TD children and in WBS, and their specificities may increase our knowledge of normal and pathological neurodevelopment and lead to new treatment strategies in a case of WBS. Indeed, it is worth to note that WBS have a strong impact on cognitive, emotional and social aspects of children's behavior in daily life. It was widely shown in animal and human studies that emotionally charged information is better memorized and retrieved than neutral one.This emotional enhancement of memory (EEM) was largely demonstrated with young and older adults independently of the nature of stimuli, the type of memory, the type of memory task and the delay between encoding and retrieval . There is general agreement about emotional regulation of memory in adults, although there are several points currently investigated.
Surprisingly, less is known about EEM in TD children and neurodevelopmental disorders such as WBS. Availability of cognitive resources and emotional regulation is supposed to have an impact on EEM. As both present specific patterns in TD children as compared to adults and in children with WBS , it could be expected that emotional regulation of memory process in TD children and WB presents also some specificities. These specificities are largely unknown, moreover if one considers that neither memory function nor emotional processing are fully developed in TD children.
Few studies that investigated EEM in TD children reported rather contradictory results. Some of them observed EEM and others did not.In addition, most studies used only negative stimuli. Even less is known about EEM in children presenting neurodevelopmental pathologies as WBS, although memory deficit for non-emotional stimuli and deficit in processing of facial expressions, especially negative ones were observed in children with WBS. In addition, a significant dissociation was documented in children with WBS, concerning memory deficit, with auditive-verbal memory rather speared and visuo-spatial memory rather impaired .
Thus, there is an important shortcoming in our understanding of emotional modulation of memory in children, both typically developing and those presenting WBS. With the present project, the investigators propose to fill this gap: two investigations will be conducted concomitantly, one of EEM in typically developing children and the other of EEM in children with WBS. Three behavioral experiments will be established to investigate EEM in this two populations, with the first experiment also including electroencephalography measures. These experiments will address the following specific questions: (1) is the EEM dependent of the stimulus type (images versus words)? - Experiment 1; (2) does the EEM exist in visuospatial episodic memory? - Experiment 2; (3) does the EEM exist for content and source memory - Experiment 3. Performance of typically developing children will be compared to young adults, and performance of children with WBS will be compared to control children matched for mental age.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Rhone Alpes
-
Lyon, Rhone Alpes, France, 69678
- Hopital Vinatier
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Children with William-Beuren syndrome
- Genetic diagnosis (CGH-Array or FISH) of microdeletion 7q11.23
- 8 to 18 years old
- Native French speaker
- Psychotropic medication unchanged during one month preceding inclusion
Typically developing children and healthy adults:
- 6 to 30 years old
- Native French speaker
- Absence of history of neurodevelopmental neurological and psychiatric disease
Exclusion Criteria:
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Atypical development
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.
|
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
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
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
|
Sham Comparator: Typical development
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.
|
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
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
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Manipulation of Valence
Time Frame: During the presentation of the stimuli or just after the presentation of the stimuli
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
EEG measures
Time Frame: During the presentation of the stimuli or just after the presentation of the stimuli
|
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
|
Source memory
Time Frame: During the presentation of the stimuli or just after the presentation of the stimuli
|
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
|
Content memory
Time Frame: During the presentation of the stimuli or just after the presentation of the stimuli
|
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
|
Spatial memory
Time Frame: During the presentation of the stimuli or just after the presentation of the stimuli
|
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
|
Recognition memory
Time Frame: During the presentation of the stimuli or just after the presentation of the stimuli
|
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
|
Modality of Valence
Time Frame: During the presentation of the stimuli or just after the presentation of the stimuli
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: DEMILY CAROLINE, CH Le Vinatier
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Nervous System Diseases
- Neurologic Manifestations
- Neurobehavioral Manifestations
- Congenital Abnormalities
- Genetic Diseases, Inborn
- Aortic Valve Disease
- Heart Valve Diseases
- Intellectual Disability
- Chromosome Disorders
- Aortic Valve Stenosis
- Aortic Stenosis, Supravalvular
- Mental Disorders
- Williams Syndrome
Other Study ID Numbers
- 2017-A03321-52
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Mental Disorders
-
Kansas State UniversityAugusta University; Dartmouth College; University of CincinnatiEnrolling by invitationMental Disorders, Severe | Mental Illness PersistentUnited States
-
VA Boston Healthcare SystemUS Department of Veterans AffairsCompletedMental Health DisordersUnited States
-
Virginia Commonwealth UniversityCompletedMental Health DisordersUnited States
-
Johns Hopkins UniversityEunice Kennedy Shriver National Institute of Child Health and Human Development...CompletedMental Health DisordersCongo
-
Norwegian University of Science and TechnologySt. Olavs HospitalCompletedMental Health DisordersNorway
-
York UniversityCanadian Institutes of Health Research (CIHR); North York General HospitalCompletedMental Health DisordersCanada
-
University of ManchesterEuropean Research CouncilRecruitingMental Disorders, SevereUnited Kingdom
-
Fundació Institut de Recerca de l'Hospital de la...Active, not recruitingMental Disorders, SevereSpain
-
University of North Carolina, Chapel HillU.S. Department of JusticeCompletedMental Disorders, SevereUnited States
-
Liga Romana pentru Sanatate MintalaPsychiatric Hospital for Chronic Patients Siret, Suceava, RomaniaUnknown
Clinical Trials on Manipulation of valence and modality
-
Hôpital le VinatierRecruiting
-
Syracuse UniversityNational Institute on Deafness and Other Communication Disorders (NIDCD)RecruitingStuttering, ChildhoodUnited States
-
University Hospital, Clermont-FerrandRecruitingPulmonary Disease, Chronic Obstructive | Oxygen Deficiency | Mitochondrial AlterationFrance
-
Hospices Civils de LyonTerminatedHealthy VolunteersFrance
-
International Clinic of Rehabilitation, UkraineCompletedCerebral Palsy, SpasticUkraine
-
Northwestern UniversityNational Institute on Deafness and Other Communication Disorders (NIDCD)RecruitingHearing Loss, Sensorineural | Amnestic Mild Cognitive Impairment | Dementia of Alzheimer TypeUnited States
-
University of UtahCompletedNon-specific Low Back PainUnited States
-
Nova Southeastern UniversityUniversity of Nevada, Las Vegas; DeRosa Physical TherapyCompleted
-
Bayside HealthVictorian Trauma FoundationUnknownTraumatic Brain InjuryAustralia
-
Ohio State UniversityNational Institute on Deafness and Other Communication Disorders (NIDCD)RecruitingUsher Syndrome | Cochlear ImplantationUnited States