Attention ControlMACBRAINNCT03872999
Attentional Control
A study testing Functional brain imaging without any contrast agent in people with Attention Control and Healthy Volunteers, run by Hospices Civils de Lyon at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Attention Control, Healthy Volunteers
- What is being tested?
- Functional brain imaging without any contrast agent
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteFrance
- Study dates
- 5 Jul 2019to 21 Jun 2021
- 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be 18 to 40 years old
Who cannot join
- 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:
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Attention Control, Healthy Volunteers
- Being tested
- Functional brain imaging without any contrast agent
- Keywords
- Attention, Control, Functional Magnetic Resonance Imaging (fMRI), Parietal, Space
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional brain imaging without any contrast agentOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Attentional Control | Experimental | Visuo-spatial attentional tasks with simple stimuli during functional magnetic resonance imaging (fMRI) scanning. Receives: Other: Functional brain imaging without any contrast agent |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of hemodynamic response in dorsal parietal regions representing specific spatial locations (visual quadrants)
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).
Measured: Day 0
Secondary outcomes (2)
Evaluation of the brain hemodynamic response
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).
Measured: 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
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).
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2019
- Study start5 Jul 2019
- Primary completion5 Jul 2019
- Study completion21 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention ControlStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe 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
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emiliano Macaluso, Prof., Principal investigator, INSERM U1028 - Equipe ImpAct CRNL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03872999
- Sponsor's protocol ID
- 69HCL19_0127
- Other IDs
- 2019-A00713-54
- Acronym
- MACBRAIN
- Status last verified
- Jan 2022
- First submitted
- 8 Mar 2019
- Last updated
- 11 Jan 2022
- 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 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Multi-scale Account of Attentional Control as the Constraining Interface Between Vision and Action (MAC-Brain).
- ClinicalTrials.gov ID
- NCT03872999
- Acronym / sponsor ID
- MACBRAIN / 69HCL19_0127
- Conditions
- Attention Control, Healthy Volunteers
- Keywords
- Attention, Control, Functional Magnetic Resonance Imaging (fMRI), Parietal, Space
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 5 Jul 2019 (actual)
- Primary completion
- 5 Jul 2019 (actual)
- Study completion
- 21 Jun 2021 (actual)
- First posted
- 13 Mar 2019 (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 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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Attentional Control | Experimental | Other: Functional brain imaging without any contrast agentVisuo-spatial attentional tasks with simple stimuli during functional magnetic resonance imaging (fMRI) scanning. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Be 18 to 40 years old
Key exclusion criteria (16 listed)
- 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.
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 |
|---|---|---|
| Functional brain imaging without any contrast agentDuring 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). | Other | Attentional Control |
Primary outcome
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).
2 secondary outcomes
Evaluation of the brain hemodynamic response
Time frame: 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
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 11 Jan 2022.
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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.
Emiliano Macaluso, Prof. principal investigator
INSERM U1028 - Equipe ImpAct CRNL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional brain imaging without any contrast agent in people with Attention Control and Healthy Volunteers, run by Hospices Civils de Lyon 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 1 inclusion and 16 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 11 Jan 2022. 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?
Changes of hemodynamic response in dorsal parietal regions representing specific spatial locations (visual quadrants) (time frame: Day 0). 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 11 Jan 2022; AzTrials last refreshed its copy on 30 Oct 2026.