Neurodevelopmental Changes (Childhood, Ageing)ULISNCT06442670
Understanding New Semantic Memory Learnings Across the Lifespan
An observational study of Neurodevelopmental Changes (Childhood, Ageing), run by University Hospital, Caen.
Trial summary
The aim of this research is to specify the changes in brain connectivity (i.e. EEG phase synchronisation between brain regions) associated with semantic learning between individuals belonging to different age groups. Read more about this study
- Who is it for?
- Ages 6 to 80 years
- Conditions the study is for
- Neurodevelopmental Changes (Childhood, Ageing)
- What is being tested?
- Electroencephalography
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Sep 2026
- Phase
- Observational
- 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 80 years
- All sexes
- Child, Adult, Older adult
Study population: Healthy volunteers
Who may be able to join
- Non-opposition by the participant or those exercising parental authority in the case of minors
- French language fluency (assessed by the investigating team)
- Absence of global cognitive deficit attested by a score on the MOCA (Montreal Cognitive Assessment) scale greater than or equal to 26/30 (test carried out at inclusion).
Who cannot join
- Person subject to a guardianship, curatorship or safeguard of justice measure
- Non affiliation to a social security scheme
Trial locations and contacts
No sites are listed yet.
About this study
The aim of this research is to specify the changes in brain connectivity (i.e. EEG phase synchronisation between brain regions) associated with semantic learning between individuals belonging to different age groups.
Read the detailed description
Semantic memory is a crucial concept in cognitive science. It has long been conceptualised as a static, amodal memory system containing knowledge about the world, concepts and symbols. Although recourse to this concept is inevitable, the mechanisms, both cognitive and neurobiological, that govern it are far from being elucidated. There are many debates and controversies in this fundamental field of cognitive science, and more specifically around the question of the acquisition and formation of knowledge in semantic memory. The literature on the development of semantic memory during ontogeny is full of contradictions.
A review of this literature highlights the many unanswered questions surrounding semantic memory. How quickly is information encoded and then consolidated into a format that justifies the term semantic knowledge? What are the neural bases underlying the formation of knowledge in semantic memory? How does semantic knowledge evolve through new episodes? How do these mechanisms evolve during ontogeny? To what extent can some semantic learning be preserved from cognitive ageing? In the face of these many questions, the literature highlights the lack of tasks enabling semantic memory to be approached in an operational manner and the need to specify the cerebral mechanisms involved at different ages of life.
The general hypotheses that will be tested as part of the ULIS project are as follows:
- New semantic learning is possible independently of episodic memory processes.
- This learning differs according to the age of the participants.
- Being tested
- Electroencephalography
- Keywords
- Semantic memory, Childhood, Ageing, EEG
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElectroencephalographyDevice
Phase synchrony during the completion of the semantic memory task
| Study group | Role | What they receive |
|---|---|---|
| 6-7 years children | Not described Receives: Device: Electroencephalography | |
| 10-11 years children | Not described Receives: Device: Electroencephalography | |
| 20-35 years adults | Not described Receives: Device: Electroencephalography | |
| 60-70 older adults | Not described Receives: Device: Electroencephalography | |
| 70-80 older adults | Not described Receives: Device: Electroencephalography |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG Phase synchrony differences between age groups
Measured: Through study completion, an average of 2 years
Secondary outcomes (1)
Behavioral performance differences between age groups (semantic memory task)
Measured: through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study startSep 2024 (estimated)
- Primary completionMay 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodevelopmental Changes (Childhood, Ageing)Studies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Caen
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Besancon
- Responsible party
- Sponsor
- Investigators
- Clémence Tomadesso, Study chair, University Hospital, Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06442670
- Sponsor's protocol ID
- 2024-A00167-40
- Acronym
- ULIS
- Status last verified
- Apr 2024
- First submitted
- 28 May 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding New Semantic Memory Learnings Across the Lifespan
- ClinicalTrials.gov ID
- NCT06442670
- Acronym / sponsor ID
- ULIS / 2024-A00167-40
- Keywords
- Semantic memory, Childhood, Ageing, EEG
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- University Hospital, CaenUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire de Besancon
- Study start
- Sep 2024 (estimated)
- Primary completion
- May 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 4 Jun 2024 (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.
The aim of this research is to specify the changes in brain connectivity (i.e. EEG phase synchronisation between brain regions) associated with semantic learning between individuals belonging to different age groups.
Detailed description
Semantic memory is a crucial concept in cognitive science. It has long been conceptualised as a static, amodal memory system containing knowledge about the world, concepts and symbols. Although recourse to this concept is inevitable, the mechanisms, both cognitive and neurobiological, that govern it are far from being elucidated. There are many debates and controversies in this fundamental field of cognitive science, and more specifically around the question of the acquisition and formation of knowledge in semantic memory. The literature on the development of semantic memory during ontogeny is full of contradictions.
A review of this literature highlights the many unanswered questions surrounding semantic memory. How quickly is information encoded and then consolidated into a format that justifies the term semantic knowledge? What are the neural bases underlying the formation of knowledge in semantic memory? How does semantic knowledge evolve through new episodes? How do these mechanisms evolve during ontogeny? To what extent can some semantic learning be preserved from cognitive ageing? In the face of these many questions, the literature highlights the lack of tasks enabling semantic memory to be approached in an operational manner and the need to specify the cerebral mechanisms involved at different ages of life.
The general hypotheses that will be tested as part of the ULIS project are as follows:
- New semantic learning is possible independently of episodic memory processes.
- This learning differs according to the age of the participants.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 6-7 years children | – | Device: Electroencephalography |
| 10-11 years children | – | Device: Electroencephalography |
| 20-35 years adults | – | Device: Electroencephalography |
| 60-70 older adults | – | Device: Electroencephalography |
| 70-80 older adults | – | Device: Electroencephalography |
Who may qualify
- Ages
- 6 to 80 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Healthy volunteers
Key inclusion criteria (3 listed)
- Non-opposition by the participant or those exercising parental authority in the case of minors
- French language fluency (assessed by the investigating team)
- Absence of global cognitive deficit attested by a score on the MOCA (Montreal Cognitive Assessment) scale greater than or equal to 26/30 (test carried out at inclusion).
Key exclusion criteria (2 listed)
- Person subject to a guardianship, curatorship or safeguard of justice measure
- Non affiliation to a social security scheme
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 |
|---|---|---|
| ElectroencephalographyPhase synchrony during the completion of the semantic memory task | Device | 10-11 years children, 20-35 years adults, 6-7 years children, 60-70 older adults, 70-80 older adults |
Primary outcome
EEG Phase synchrony differences between age groups
Time frame: Through study completion, an average of 2 years
1 secondary outcome
Behavioral performance differences between age groups (semantic memory task)
Time frame: through study completion, an average of 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
- Individual participant dataSharing planned: Undecided
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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.
Clémence Tomadesso study chair
University Hospital, Caen
Questions about this trial
What is this clinical trial studying?
An observational study of Neurodevelopmental Changes (Childhood, Ageing), run by University Hospital, Caen.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thomas Hinault, PhD (+33231568140, thomas.hinault@inserm.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG Phase synchrony differences between age groups (time frame: Through study completion, an average of 2 years). 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 4 Jun 2024.