Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05764863
Other study ID # 22-PP-21
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 9, 2023
Est. completion date December 31, 2024

Study information

Verified date May 2024
Source Centre Hospitalier Universitaire de Nice
Contact Lydiane MONDOT
Phone 0492038187
Email mondot.l@chu-nice.Fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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).


Recruitment information / eligibility

Status Recruiting
Enrollment 30
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Radiation:
fMRI
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.

Locations

Country Name City State
France Nice University Hospital Nice

Sponsors (1)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Behavioral measure Reaction time (ms) across experimental conditions during the fMRI
Secondary Brain measure 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
See also
  Status Clinical Trial Phase
Recruiting NCT06052553 - A Study of TopSpin360 Training Device N/A
Completed NCT05511077 - Biomarkers of Oat Product Intake: The BiOAT Marker Study N/A
Recruiting NCT04632485 - Early Detection of Vascular Dysfunction Using Biomarkers From Lagrangian Carotid Strain Imaging
Completed NCT05931237 - Cranberry Flavan-3-ols Consumption and Gut Microbiota in Healthy Adults N/A
Completed NCT04527718 - Study of the Safety, Tolerability and Pharmacokinetics of 611 in Adult Healthy Volunteers Phase 1
Terminated NCT04556032 - Effects of Ergothioneine on Cognition, Mood, and Sleep in Healthy Adult Men and Women N/A
Completed NCT04998695 - Health Effects of Consuming Olive Pomace Oil N/A
Completed NCT04065295 - A Study to Test How Well Healthy Men Tolerate Different Doses of BI 1356225 Phase 1
Completed NCT04107441 - AX-8 Drug Safety, Tolerability and Plasma Levels in Healthy Subjects Phase 1
Completed NCT01442831 - Evaluate the Absorption, Metabolism, And Excretion Of Orally Administered [14C] TR 701 In Healthy Adult Male Subjects Phase 1
Terminated NCT05934942 - A Study in Healthy Women to Test Whether BI 1358894 Influences the Amount of a Contraceptive in the Blood Phase 1
Recruiting NCT05525845 - Studying the Hedonic and Homeostatic Regulation of Food Intake Using Functional MRI N/A
Completed NCT05515328 - A Study in Healthy Men to Test How BI 685509 is Processed in the Body Phase 1
Completed NCT05030857 - Drug-drug Interaction and Food-effect Study With GLPG4716 and Midazolam in Healthy Subjects Phase 1
Completed NCT04967157 - Cognitive Effects of Citicoline on Attention in Healthy Men and Women N/A
Recruiting NCT04714294 - Evaluate the Safety, Tolerability and Pharmacokinetics Characteristics of HPP737 in Healthy Volunteers Phase 1
Recruiting NCT04494269 - A Study to Evaluate Pharmacokinetics and Safety of Tegoprazan in Subjects With Hepatic Impairment and Healthy Controls Phase 1
Completed NCT04539756 - Writing Activities and Emotions N/A
Recruiting NCT04098510 - Concentration of MitoQ in Human Skeletal Muscle N/A
Completed NCT03308110 - Bioavailability and Food Effect Study of Two Formulations of PF-06650833 Phase 1