- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03872999
Attentional Control (MACBRAIN)
January 10, 2022 updated by: Hospices Civils de Lyon
Developing a Multi-scale Account of Attentional Control as the Constraining Interface Between Vision and Action (MAC-Brain).
The project is dedicated to understanding the integration within the brain of signals of different natures that contribute to attentional control.
The investigator will make use of standardized experimental displays involving the discrimination of a target (tilted-bar) presented together with 3 distractor items, with one stimulus in each visual quadrant.
Across three fMRI experiments in healthy participants, the investigator will manipulate different types of signals that will guide the subject's attention towards one of the four quadrants: Exp 1 - task instruction & item salience; Exp 2 - probabilistic target location; Exp 3 - probabilistic reward.
The investigator expects that irrespective of the nature of the control signal, activity in dorsal parietal cortex will index the currently relevant/attended location.
Moreover, The investigator expects that upon changes of the most relevant location, one will observe activation of the ventral parietal cortex, plus increased inter-regional connectivity between ventral and dorsal parietal regions - again irrespective of the nature of the attention guiding signals.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
76
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
-
-
-
Bron, France, 69676
- Inserm U1028 Equipe Impact
-
-
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 40 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Be 18 to 40 years old
Exclusion Criteria:
- Previous neurologic or psychiatric disease.
- Cognitive deficits restricting understanding of the tasks.
- Pregnant or breath-feeding women.
- Persons under guardianship, curator or any other administrative or judicial measure of deprivation of rights or liberty.
- Subjects currently participating in other study.
Additional exclusion criteria for a functional magnetic resonance imaging (fMRI) recording:
- Neurologic, cardiac electrostimulation or defibrillator.
- Cardiac prostheses
- Intracranial clips or clamps
- Cerebrospinal fluid disorders
- Metal particles in the eyes
- Metal dental or articular prostheses
- Diffusion pomp or other infusion system
- Claustrophobia
- Head tattoo, make-up, hair gel
- Have any copper intrauterine device
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: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Attentional Control
Visuo-spatial attentional tasks with simple stimuli during functional magnetic resonance imaging (fMRI) scanning.
|
During the functional magnetic resonance imaging (fMRI) protocol, the subject will perform the attentional task while whole-brain activity will be recorded using Echo Planar Imaging (EPI) that measures the Blood Oxygen Level Dependent (BOLD) signal (2x2x2 isotropic voxels, Echo Time (ET) = 30 ms, Repetition Time (RT) = 2.5 sec).
The functional session will be subdivided into several parts ("Runs", duration: 10-15 min).
Together with the functional data, the protocol will include a structural scan (T1 weighted, 1x1x1 mm voxels; duration 5-7 min) and a field mapping sequence (duration: 1 min).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes of hemodynamic response in dorsal parietal regions representing specific spatial locations (visual quadrants)
Time Frame: Day 0
|
After spatial pre-processing of individual series of functional magnetic resonance imaging (fMRI) scans, normalization and smoothing as suggested for Statistical Parametric Mapping (SPM) analysis, the different attentional conditions will be modeled and convolved with canonical Hemodynamic Response Function (HRF).
The model will be estimated according to the algorithm of SPM.
Using a Region of Interest (ROI) approach, the investigator will extract the signal in dorsal parietal regions representing the four visual quadrants, and will compare activity as a function of the attended / most relevant location.
The main hypothesis will be confirmed by activation of the ROI corresponding to the currently attended location, irrespective of the nature of the signal guiding attention (i.e. common effects in Exp 1-3).
|
Day 0
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluation of the brain hemodynamic response
Time Frame: Day 0
|
The investigator will search for relations between changes over time of the most relevant location (trial history) and the re-organization of attentional representations by investigating the activity and connectivity of the ventral parietal cortex.
For this, the investigator will model events corresponding to changes in attention location and test for local activation of the ventral parietal cortex, as well as changes in connectivity (correlation) between ventral and dorsal parietal regions.
The secondary hypothesis will be confirmed by increased activation in ventral parietal cortex, plus increased connectivity between ventral and dorsal parietal regions, at the time of a change of the most relevant location, irrespective of the nature of the signal guiding attention (i.e. common effects in Exp 1-3).
|
Day 0
|
Evaluation of the connectivity of the ventral parietal cortex at the time when there is a change of the most relevant spatial location/visual quadrant. x²
Time Frame: Day 0
|
The investigator will search for relations between changes over time of the most relevant location (trial history) and the re-organization of attentional representations by investigating the activity and connectivity of the ventral parietal cortex.
For this, the investigator will model events corresponding to changes in attention location, and test for local activation of the ventral parietal cortex, as well as changes of connectivity (correlation) between ventral and dorsal parietal regions.
The secondary hypothesis will be confirmed by increased activation in ventral parietal cortex, plus increased connectivity between ventral and dorsal parietal regions, at the time of a change of the most relevant location, irrespective of the nature of the signal guiding attention (i.e. common effects in Exp 1-3).
|
Day 0
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Emiliano Macaluso, Prof., INSERM U1028 - Equipe ImpAct CRNL
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)
July 5, 2019
Primary Completion (ACTUAL)
July 5, 2019
Study Completion (ACTUAL)
June 21, 2021
Study Registration Dates
First Submitted
March 8, 2019
First Submitted That Met QC Criteria
March 11, 2019
First Posted (ACTUAL)
March 13, 2019
Study Record Updates
Last Update Posted (ACTUAL)
January 11, 2022
Last Update Submitted That Met QC Criteria
January 10, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 69HCL19_0127
- 2019-A00713-54 (OTHER: ID-RCB)
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.
Clinical Trials on Healthy Volunteers
-
AstraZenecaCompletedHealthy Elderly Volunteers | Healthy Young VolunteersUnited States
-
Syndax PharmaceuticalsCompletedHealthy Volunteers | Volunteers | Normal Volunteers | Human VolunteersUnited States
-
Syndax PharmaceuticalsCompletedHealthy Volunteers | Volunteers | Normal Volunteers | Human VolunteersUnited States
-
University Hospital, Clermont-FerrandUnite de Nutrition Humaine UMR 1019- INRAE; Unite MetaGenoPolis INRAE; France...CompletedHealthy Volunteers | Frail VolunteersFrance
-
Galera Therapeutics, Inc.CelerionCompletedHealthy | Healthy VolunteersUnited States
-
Newcastle UniversityCompletedGI Glycaemic Index Healthy Volunteers | GL Glycaemic Load Healthy VolunteersUnited Kingdom
-
Galera Therapeutics, Inc.Syneos HealthCompleted
-
Galera Therapeutics, Inc.Syneos HealthCompletedHealthy | Healthy VolunteersAustralia
-
Maastricht University Medical CenterCompletedHealthy Volunteers | Healthy Subjects | Healthy AdultsNetherlands
-
PMV Pharmaceuticals, IncRecruitingHealthy VolunteersUnited States
Clinical Trials on Functional brain imaging without any contrast agent
-
Hospices Civils de LyonCompletedHealthy VolunteersFrance
-
IRCCS Policlinico S. DonatoCompletedAbdominal Aortic AneurismItaly
-
Sidney Kimmel Cancer Center at Thomas Jefferson...National Cancer Institute (NCI); University of California, San Diego; GE Healthcare and other collaboratorsCompletedHepatocellular Carcinoma | Chemoembolization, TherapeuticUnited States
-
Children's Hospital Medical Center, CincinnatiRecruiting
-
Bristol-Myers SquibbPfizerCompletedThrombosisArgentina, United States, Germany, Mexico, Canada, Netherlands, Brazil, Austria, United Kingdom
-
University Hospital, BordeauxUnknown
-
Lia BallyETH ZurichCompletedObesity | Food PreferencesSwitzerland
-
Assistance Publique Hopitaux De MarseilleUnknownChronic Obstructive Pulmonary Disease (COPD)France
-
Chinese PLA General HospitalRecruitingParkinson's Disease | Magnetic Resonance Imaging | Deep Brain StimulationChina
-
NYU Langone HealthCompletedAlzheimer DiseaseUnited States