- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05764863
fMRI Study of the Cerebal Bases of the Spatialization Process in Working Memory (IRMF-SPAT)
December 17, 2024 updated by: Centre Hospitalier Universitaire de Nice
fMRI Study of the Cerebal Bases of the Spatialization Process in Working Memory in Young Healthy Adults
The present neuroimaging study investigates cerebral and behavioral markers of spatialization.
Spatialization in memory corresponds to a mental representation of successive items from left to right in Westerners.
A simple task to detect spatialization consists in presenting a series of stimuli sequentially.
All stimuli are centered on the screen, so there is no spatial information during the task.
After the presentation of the sequence, there is a recognition phase in which the participant is requested to take a decision as to whether a memory probe belongs to the sequence maintained in memory.
The decision is made by pressing a key with the left or the right hand, depending on the instruction.
The main measure is the difference in response times between the two hands.
The standard spatialization effect in working memory in Westerners is that left-key responses are faster when retrieving the first items of the sequence whereas later items elicit faster right-key responses.
To date, the factors that can influence this spatialization process in working memory as well as the brain structures involved remain largely unknown.
Participants need to complete three experimental conditions associated with fMRI recording of brain activity.
In task A (Visual Spatial), participants will see the sequences presented from left to right; in task B (Visual No Spatial), participants will see sequences of items presented in the middle of the screen; and in task C (Auditory), the sequences will be presented in an auditory format.
When comparing tasks, A and B, we will be able to investigate if seeing information from left to right (spatialization is provided through the spatial coordinates of the items) is comparable to spatializing information from left to right (spatialization is not provided, all items have the same spatial coordinates).
The comparison between task B and C will allow us to investigate the effect of seeing items (spatialization is not provided, all items have the same spatial coordinates) versus hearing them (spatialization is not provided and items have no spatial coordinates).
Study Overview
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nice, France, 06000
- Nice University Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 35 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- right-handed adult subjects
- between 18 and 35 years of age,
- affiliated to or benefiting from a social security system
- having signed a prior informed consent.
Exclusion Criteria:
- minors
- subjects aged 36 years and older,
- left-handed,
- neurological disorders contraindicating fMRI examinations,
- protected by law under guardianship or curatorship, or unable to participate in a clinical study under Article L. 1121-16 of the French Public Health Code.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: young healthy adults
Participants need to complete three experimental conditions associated with fMRI recording of brain activity.
In condition A (Visual Spatial), participants will see the sequences presented from left to right; in condition B (Visual No Spatial), participants will see sequences of items presented in the middle of the screen; and in condition C (Auditory), the sequences will be presented in an auditory format.
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The participant will then complete a series of working memory tasks under three distinct conditions as described above (visual spatial, visual non-spatial, auditory).
The instructions and tasks will be administered via an MRI compatible monitor and headset system (NordicNeuroLab).
During the tasks, the participant's brain activity will be recorded.
Finally, at the end of the experiment, a high-resolution anatomical image of the brain will be acquired in order to facilitate the subsequent data processing steps and to define the position of the interparietal sulcus for each subject.
The visit will be completed by a visual imaging questionnaire.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Behavioral measure
Time Frame: during the fMRI
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Reaction time (ms) across experimental conditions
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during the fMRI
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Brain measure
Time Frame: through study completion, an average of 2 years
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Brain activity recorded using fMRI device across experimental conditions level of Blood-Oxygen-Level-Dependant (BOLD) effect |
through study completion, an average of 2 years
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 9, 2023
Primary Completion (Actual)
April 19, 2024
Study Completion (Actual)
December 17, 2024
Study Registration Dates
First Submitted
February 16, 2023
First Submitted That Met QC Criteria
March 10, 2023
First Posted (Actual)
March 13, 2023
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
December 17, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Other Study ID Numbers
- 22-PP-21
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
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.