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Attentional Control (MACBRAIN)

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ClinicalTrials.gov Identifier: NCT03872999
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : July 10, 2019
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Attention Control Healthy Volunteers Other: Functional brain imaging without any contrast agent Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 76 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Developing a Multi-scale Account of Attentional Control as the Constraining Interface Between Vision and Action (MAC-Brain).
Actual Study Start Date : July 5, 2019
Estimated Primary Completion Date : January 5, 2022
Estimated Study Completion Date : January 5, 2022

Arm Intervention/treatment
Experimental: Attentional Control
Visuo-spatial attentional tasks with simple stimuli during functional magnetic resonance imaging (fMRI) scanning.
Other: Functional brain imaging without any contrast agent
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).




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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).

  2. 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).



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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03872999


Contacts
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Contact: Emiliano Macaluso, Prof. 4 72 91 34 26 ext 33 emiliano.macaluso@univ-lyon1.fr
Contact: Beffara Bertrand 4 72 91 34 07 ext 33 bertrand.beffara@inserm.fr

Locations
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France
Inserm U1028 Equipe Impact Recruiting
Bron, France, 69676
Contact: Emiliano MACALUSO    4 72 91 34 07 ext +33    emiliano.macaluso@univ-lyon1.fr   
Contact: BErtrand BEFFARA    4 72 91 34 07 ext +33    bertrand.beffara@etu.univ-lyon1.fr   
Principal Investigator: Emiliano MACALUSO         
Sub-Investigator: Fadila Hadj-Bouziane         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Emiliano Macaluso, Prof. INSERM U1028 - Equipe ImpAct CRNL

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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT03872999     History of Changes
Other Study ID Numbers: 69HCL19_0127
2019-A00713-54 ( Other Identifier: ID-RCB )
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: July 10, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Hospices Civils de Lyon:
Attention
Control
Functional Magnetic Resonance Imaging (fMRI)
Parietal
Space