Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06349213
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-03-21
Brief Title:
Uncovering the Cognitive and Neural Mechanisms Underlying Cognitive Time
Sponsor:
Institut National de la Santé Et de la Recherche Médicale France
Organization:
Institut National de la Santé Et de la Recherche Médicale France
Study Overview
Official Title:
Uncovering the Cognitive and Neural Mechanisms Underlying Cognitive Time
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
TIMES
Brief Summary:
Time processing the ability to process and encode temporal information is essential for cognitive functioning and for a large number of daily life activities In particular the processing of durations of several seconds is central to cognition impaired in several pathologies and has been associated with cognitive changes with advancing age While behavioral studies have been conducted to specify the neural bases of temporal cognition and their association with other cognitive functions the mechanisms underlying age-related changes and individual differences remain unknown The project will characterize ageing effects on timing mechanisms and their neural underpinnings Building on recent advances from neuroscience and age-related cognitive changes the project focuses on the precision of duration processing that declines with age and the associated neural bases Participants will perform a duration judgement task while a electroencephalography and b functional magnetic resonance imaging activity are simultaneously recorded to investigate age effects on structural and functional network connectivity In addition striatal dopamine will be measured using a FDOPA PETscan Evaluation of other temporal cognition processes and general cognition will also be performed This combination offers a unique opportunity to accurately specifying the neurophysiological underpinning of aging effects on time processing changes This project will further our understanding of the variability of cognitive performance with advancing age and contribute to identifying new measures of temporal impairments
Detailed Description:
The main research examinations for all participants will be divided into two initial visits V1 approximately 35 hours and V2 approximately 25 hours at the GIP Cyceron neuroimaging center premises
As part of the longitudinal follow-up older participants only will complete one follow-up session visits V3 V4 and V5 of approximately two and a half hours per year at the PMRCI premises for three years after visit 2
During the various visits participants may be accompanied by a support person of their choice
The first visit will last approximately 3 and a half hours and will consist of two parts
- First part of visit 1 Inclusion medical visit V1 GIP Cyceron The first part of Visit 1 will be carried out at GIP Cyceron after a cooling-off period of at least 7 days from the day of the telephone interview and will last approximately 1 hour It will begin with the information and consent procedure carried out by an investigator registered with the Order of Physicians or his or her designated representative and registered on the task delegation list Participants will be informed of the purpose recipients and retention periods for all data collected as part of their participation in the research
Prior to signing the consent form the eligibility criteria inclusion and non-inclusion criteria will be checked by the investigator The visit also includes the taking of a medical history and current treatments
- Second part of Visit 1 V1 GIP Cyceron simultaneous EEG-fMRI neuropsychological assessment The second part of the V1 visit will be carried out at GIP Cyceron and will last approximately 2 and a half hours It will begin with a urine pregnancy test for women of childbearing age and verification that there are no contraindications to the MRI examination The EEG-MRI imaging will then last approximately 15 hours followed by a 15-30 minute break Finally the neuropsychological evaluation will last about an hour and will include the performance of some of the neuropsychological tests and self-questionnaires in the presence of members of the investigating team The tests and self-questionnaires will last approximately one hour and will be adjusted according to each individuals completion time and any level of fatigue
During this visit participants will perform a temporal judgement task while EEG and fMRI functional data are being recorded Anatomical data will also be collected The accuracy of time processing will be assessed in the MRI using bisection and temporal generalisation tasks
Visit 2 V2 GIP Cyceron maximum one month after V1 PET scan and neuropsychological assessment The V2 visit will be carried out at GIP Cyceron approximately one month after visit 1 and will last about 2 and a half hours A telephone call from the project leader will enable this visit to be scheduled Participants will be asked to have fasted for at least 4 hours at the time of the visit with no restriction on fluid intake The visit will begin with PET imaging for approximately 15 hours followed by a 15-30 minute break For women of childbearing age a urine pregnancy test will be performed prior to the PET scan The neuropsychological assessment described in V1 will also be carried out for approximately one hour in the presence of members of the investigating team
The dopaminergic status of the nigrostriatal pathway will be explored in vivo using a Discovery RX VCT 64 whole-body PET-CT scanner General Electric Healthcare maximum axial FAV 50cm The investigator will use 18F-FDOPA DOPACIS a fluorine-18 labelled radiopharmaceutical This radiopharmaceutical indirectly reflects the number of dopaminergic neurons via the enzymatic activity of dopa-decarboxylase within these neurons
Visits 3 4 5 PMRCI approximately once a year following V2
The procedure for these three visits is identical Participants will be contacted by the project leader to plan these visits Only elderly participants will be included in the longitudinal follow-up The elderly participants will first perform the temporal judgement task performed in V1 while the EEG activity is being recorded approximately 15 hours Following a 15-30 minute break all the neuropsychological measures tests and self-questionnaires described above will be carried out approximately 15 hours These visits will take place one two and three years after the second visit Only older individuals will be included in the longitudinal follow-up in order to identify the factors associated with the variability of cognitive trajectories which is greater during the ageing process
At each follow-up visit visits 3 4 5 the investigator will check that the participant is not under legal protection guardianship curators or safeguard of justice as well as the absence of global cognitive deficit attested by a score on the MOCA scale greater than or equal to 2630 If this is the case the participant will not be able to continue to take part in the research The tutorsupervisor will be informed of this condition
As part of the longitudinal follow-up older participants only will complete one follow-up session visits V3 V4 and V5 of approximately two and a half hours per year at the PMRCI premises for three years after visit 2
During the various visits participants may be accompanied by a support person of their choice
The first visit will last approximately 3 and a half hours and will consist of two parts
- First part of visit 1 Inclusion medical visit V1 GIP Cyceron The first part of Visit 1 will be carried out at GIP Cyceron after a cooling-off period of at least 7 days from the day of the telephone interview and will last approximately 1 hour It will begin with the information and consent procedure carried out by an investigator registered with the Order of Physicians or his or her designated representative and registered on the task delegation list Participants will be informed of the purpose recipients and retention periods for all data collected as part of their participation in the research
Prior to signing the consent form the eligibility criteria inclusion and non-inclusion criteria will be checked by the investigator The visit also includes the taking of a medical history and current treatments
- Second part of Visit 1 V1 GIP Cyceron simultaneous EEG-fMRI neuropsychological assessment The second part of the V1 visit will be carried out at GIP Cyceron and will last approximately 2 and a half hours It will begin with a urine pregnancy test for women of childbearing age and verification that there are no contraindications to the MRI examination The EEG-MRI imaging will then last approximately 15 hours followed by a 15-30 minute break Finally the neuropsychological evaluation will last about an hour and will include the performance of some of the neuropsychological tests and self-questionnaires in the presence of members of the investigating team The tests and self-questionnaires will last approximately one hour and will be adjusted according to each individuals completion time and any level of fatigue
During this visit participants will perform a temporal judgement task while EEG and fMRI functional data are being recorded Anatomical data will also be collected The accuracy of time processing will be assessed in the MRI using bisection and temporal generalisation tasks
Visit 2 V2 GIP Cyceron maximum one month after V1 PET scan and neuropsychological assessment The V2 visit will be carried out at GIP Cyceron approximately one month after visit 1 and will last about 2 and a half hours A telephone call from the project leader will enable this visit to be scheduled Participants will be asked to have fasted for at least 4 hours at the time of the visit with no restriction on fluid intake The visit will begin with PET imaging for approximately 15 hours followed by a 15-30 minute break For women of childbearing age a urine pregnancy test will be performed prior to the PET scan The neuropsychological assessment described in V1 will also be carried out for approximately one hour in the presence of members of the investigating team
The dopaminergic status of the nigrostriatal pathway will be explored in vivo using a Discovery RX VCT 64 whole-body PET-CT scanner General Electric Healthcare maximum axial FAV 50cm The investigator will use 18F-FDOPA DOPACIS a fluorine-18 labelled radiopharmaceutical This radiopharmaceutical indirectly reflects the number of dopaminergic neurons via the enzymatic activity of dopa-decarboxylase within these neurons
Visits 3 4 5 PMRCI approximately once a year following V2
The procedure for these three visits is identical Participants will be contacted by the project leader to plan these visits Only elderly participants will be included in the longitudinal follow-up The elderly participants will first perform the temporal judgement task performed in V1 while the EEG activity is being recorded approximately 15 hours Following a 15-30 minute break all the neuropsychological measures tests and self-questionnaires described above will be carried out approximately 15 hours These visits will take place one two and three years after the second visit Only older individuals will be included in the longitudinal follow-up in order to identify the factors associated with the variability of cognitive trajectories which is greater during the ageing process
At each follow-up visit visits 3 4 5 the investigator will check that the participant is not under legal protection guardianship curators or safeguard of justice as well as the absence of global cognitive deficit attested by a score on the MOCA scale greater than or equal to 2630 If this is the case the participant will not be able to continue to take part in the research The tutorsupervisor will be informed of this condition
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2023-A02263-42 | OTHER | Secondary ID | None |