- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07851051
Study of Individual Neurocognitive Changes Associated With the Training of the Working Memory. (SAMPLEX)
Study of Individual Neurocognitive Changes Associated With the Training of the Working Memory(SAMPLEX)
8 participants including 2 pilots. The 2 pilot participants will each execute an MRI acquisition session in order to adjust the experimental paradigm
Studieoversigt
Status
Betingelser
Detaljeret beskrivelse
The participants will benefit from a comprehensive training program in the Memory of the taught by the computerized CogMed method. This training showed a positive effect for improve the skills in Memory of the working in the healthy subject
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: CACHIA Arnaud
- Telefonnummer: 0661519200
- E-mail: arnaud.cachia@u-paris.fr
Studiesteder
-
-
-
Paris, Frankrig, 75014
- Rekruttering
- CACHIA
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
healthy adult volunteers aged 18 to 30 who have no contraindications to an MRI scan.
Beskrivelse
Inclusion Criteria:
The inclusion criteria include
- age between 18 and 30 years,
- right-handedness (assessed using the Edinburgh Handedness Inventory),
- native French speaker, affiliation with the French national health insurance system
- provision of written informed consent prior to participation.
Exclusion Criteria:
Exclusion criteria include:
- contraindications to MRI,
- neurological or psychiatric disorders
- history of traumatic brain injury
- any geographical or psychological condition preventing full compliance with the study protocol.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: CASE_ONLY
- Tidsperspektiver: OTHER
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Working memory performance - Cogmed
Tidsramme: 5 week.
|
Cognitive trajectories will be characterized using performance measures derived from the home-based training. |
5 week.
|
|
Working memory performance - CANTAB
Tidsramme: 2 week
|
Cognitive trajectories will be characterized using performance measures derived from the Spatial Span (SSP) task from the CANTAB battery, administered under standardized conditions at GHU Paris Psychiatry and Neurosciences. |
2 week
|
|
Multimodal MRI data
Tidsramme: 2 week
|
Multimodal MRI data - including anatomical, resting-state, working memory (WM) task-based functional, and diffusion-weighted sequences - will be acquired repeatedly over a six-week period during WM training, as well as before and after the training phase. |
2 week
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
executive functions performance
Tidsramme: 1 week
|
To enable complementary analyses of non-trained executive functions (EF), the participant will complete three tasks from the NIH Toolbox Cognitive Battery. |
1 week
|
|
behavioral variables
Tidsramme: 5 week for most variables
|
At baseline, we will collect demographic and cognitive information including age, sex, years of education, and baseline cognitive performance. In addition, we will record a set of covariates related to the participant's state during the scanning session and within the 24 hours preceding each training session. |
5 week for most variables
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: CACHIA Arnaud, hospital saint anne of the GHU Paris
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- D25-P007
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .