HealthyIRMF-SPATNCT05764863
fMRI Study of the Cerebal Bases of the Spatialization Process in Working Memory
A study testing fMRI in people with Healthy, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- fMRI
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jun 2023to 17 Dec 2024
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
- Conditions
- Healthy
- Being tested
- fMRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRIRadiation
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.
| Study group | Role | What they receive |
|---|---|---|
| young healthy adults | Experimental | 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. Receives: Radiation: fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Behavioral measure
Reaction time (ms) across experimental conditions
Measured: during the fMRI
Secondary outcomes (1)
Brain measure
Brain activity recorded using fMRI device across experimental conditions
level of Blood-Oxygen-Level-Dependant (BOLD) effect
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 posted13 Mar 2023
- Study start9 Jun 2023
- Primary completion19 Apr 2024
- Study completion17 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- One group of 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.
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05764863
- Sponsor's protocol ID
- 22-PP-21
- Acronym
- IRMF-SPAT
- Status last verified
- May 2024
- First submitted
- 16 Feb 2023
- Last updated
- 20 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- fMRI Study of the Cerebal Bases of the Spatialization Process in Working Memory in Young Healthy Adults
- ClinicalTrials.gov ID
- NCT05764863
- Acronym / sponsor ID
- IRMF-SPAT / 22-PP-21
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 9 Jun 2023 (actual)
- Primary completion
- 19 Apr 2024 (actual)
- Study completion
- 17 Dec 2024 (actual)
- First posted
- 13 Mar 2023 (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 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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- One group of 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.
| Arm | Type | Receives |
|---|---|---|
| young healthy adults | Experimental | Radiation: fMRIParticipants 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| fMRIThe 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. | Radiation | young healthy adults |
Primary outcome
Behavioral measure
Time frame: during the fMRI
Reaction time (ms) across experimental conditions
1 secondary outcome
Brain measure
Time frame: through study completion, an average of 2 years
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 20 Dec 2024.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fMRI in people with Healthy, run by Centre Hospitalier Universitaire de Nice 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 4 inclusion and 5 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 20 Dec 2024. 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. 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?
Behavioral measure (time frame: during the fMRI). 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 20 Dec 2024.