Mental DisordersEEM-TAdevNCT03688516
Effects of Emotion on Episodic Memory in Typically Developing Children and Children With Williams-Beuren Syndrome
A study testing Manipulation of valence and modality, Spatial and recognition memory and Source and content memory in people with Mental Disorders, run by Hôpital le Vinatier at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Disorders
- What is being tested?
- Manipulation of valence and modality, Spatial and recognition memory and Source and content memory
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- 1 siteFrance
- Study dates
- 28 Jun 2018to 15 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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:
Show all 9Show fewer
- 6 to 30 years old
- Native French speaker
- Absence of history of neurodevelopmental neurological and psychiatric disease
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Mental Disorders
- Being tested
- Manipulation of valence and modality, Spatial and recognition memory, Source and content memory
- Keywords
- emotion, memory, Williams-Beuren syndrome
- Medical subject headings
- Mental Disorders, Williams Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manipulation of valence and modalityBehavioural
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
Spatial and recognition memoryBehavioural
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
Source and content memoryBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Manipulation of valence and modality; Behavioral: Spatial and recognition memory; Behavioral: 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. Receives: Behavioral: Manipulation of valence and modality; Behavioral: Spatial and recognition memory; Behavioral: Source and content memory |
What is being measured
The primary outcome is the main question the study is designed to answer.
Manipulation of Valence
Behavioral measure:number of correct responses (correct recall and correct recognition), evoked potential for EEG only for Experiment 1
Measured: During the presentation of the stimuli or just after the presentation of the stimuli
Secondary outcomes (6)
EEG measures
Number of correct responses (correct recall and correct recognition), evoked potential for EEG only for Experiment 1
Measured: During the presentation of the stimuli or just after the presentation of the stimuli
Source memory
Number of correct responses (correct recall and correct recognition), evoked potential for EEG only for Experiment 1
Measured: During the presentation of the stimuli or just after the presentation of the stimuli
Content memory
Number of correct responses (correct recall and correct recognition), evoked potential for EEG only for Experiment 1
Measured: During the presentation of the stimuli or just after the presentation of the stimuli
Spatial memory
Behavioral measure:number of correct responses (correct recall and correct recognition), evoked potential for EEG only for Experiment 1
Measured: During the presentation of the stimuli or just after the presentation of the stimuli
Recognition memory
Behavioral measure:number of correct responses (correct recall and correct recognition), evoked potential for EEG only for Experiment 1
Measured: During the presentation of the stimuli or just after the presentation of the stimuli
Modality of Valence
Behavioral measure:number of correct responses (correct recall and correct recognition), evoked potential for EEG only for Experiment 1
Measured: During the presentation of the stimuli or just after the presentation of the stimuli
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Sep 2018
- Study start28 Jun 2018
- Primary completion15 Dec 2020
- Study completion15 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 280 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital le Vinatier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- DEMILY CAROLINE, Principal investigator, CH LE VINATIER
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03688516
- Sponsor's protocol ID
- 2017-A03321-52
- Acronym
- EEM-TAdev
- Status last verified
- Feb 2021
- First submitted
- 2 Jul 2018
- Last updated
- 9 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Emotion on Episodic Memory in Typically Developing Children and Children With Williams-Beuren Syndrome
- ClinicalTrials.gov ID
- NCT03688516
- Acronym / sponsor ID
- EEM-TAdev / 2017-A03321-52
- Conditions
- Mental Disorders
- Keywords
- emotion, memory, Williams-Beuren syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 280 participants (actual)
- Lead sponsor
- Hôpital le VinatierUniversity, hospital or other
- Study start
- 28 Jun 2018 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 15 Dec 2020 (actual)
- First posted
- 28 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Atypical development | Experimental | Behavioral: Manipulation of valence and modality, Behavioral: Spatial and recognition memory, Behavioral: Source and content memory30 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. |
| Typical development | Sham comparator | Behavioral: Manipulation of valence and modality, Behavioral: Spatial and recognition memory, Behavioral: Source and content memory30 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. |
Who may qualify
- Ages
- 6 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manipulation of valence and modalitymnemic 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 | Behavioural | Atypical development, Typical development |
| Spatial and recognition memorymnemic 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 | Behavioural | Atypical development, Typical development |
| Source and content memorymnemic 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 | Behavioural | Atypical development, Typical development |
Primary outcome
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
6 secondary outcomes
EEG measures
Time frame: 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
Content memory
Time frame: 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
Recognition memory
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
DEMILY CAROLINE principal investigator
CH LE VINATIER
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manipulation of valence and modality, Spatial and recognition memory and Source and content memory in people with Mental Disorders, run by Hôpital le Vinatier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Manipulation of Valence (time frame: During the presentation of the stimuli or just after the presentation of the stimuli). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2021; AzTrials last refreshed its copy on 1 Nov 2026.