- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04279158
Attention Modulation of Local and Global Inhibition Mechanisms (MILGattention)
Human behavior is both flexible and adapted to the environmental context through inhibition capabilities; the investigator control the subject's behavior by repressing inappropriate responses and selecting, among several possibilities, those that are appropriate. These mechanisms are not independent of attentional control. Attention acts as a selection filter for the investigator's behavior. This leads us to hypothesize that attention modulates the mechanisms of inhibition. Nevertheless, the different brain structures involved, as well as mechanisms underlying the interaction between inhibition and attention remain largely unknown.
Previous research has suggested that inhibition requires selective attention and, conversely, attentional mechanisms would result in the "deselection", or inhibition, of objects in space or irrelevant actions. Reconciling the literature on attention with the one on inhibition appears fundamental for the understanding of the instance to which the mechanisms of inhibition and the cognitive processes interact. Therefore, the goal of this research project will be to investigate how inhibition mechanisms are implemented in the brain and, in more detail, what determines the type of resulting inhibitory control: spatially localized or global. The investigator will test 3 different patient groups (optic ataxia, hemispatial neglect and attention-deficit hyperactivity disorder) compared to control.
In conclusion, this research project will aim to develop a theoretical model of the interaction between attentional control and inhibition mechanisms in order to improve diagnostic and rehabilitation tools in the future.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Julie OUERFELLI-ETHIER
- Email: julie.ouerfelli-ethier@inserm.fr
Study Contact Backup
- Name: laure PISELLA, PhD
- Phone Number: +33 4 72 91 34 05
- Email: laure.pisella@inserm.fr
Study Locations
-
-
-
Bron, France, 69500
- Recruiting
- Centre de Recherche en Neuroscience de Lyon
-
Contact:
- Julie OUERFELLI-ETHIER
- Email: julie.ouerfelli-ethier@inserm.fr
-
Contact:
- laure PISELLA, PhD
- Phone Number: +33 4 72 91 34 05
- Email: laure.pisella@inserm.fr
-
Principal Investigator:
- laure PISELLA, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
All patients and healthy subjects:
Inclusion Criteria:
- male and female, age from 18 to 75 years included
- normal vision or corrected vision
- covered by social security
- signed written informed consent
Exclusion Criteria:
- unable to comply with requirements of the study (neurological, psychiatric, sensory or motor troubles)
- adults under legal protection
Patient with hemispatial neglect:
Inclusion Criteria:
- After a stroke (> 1 month ago), presence of a neurological impairment documented by brain imaging (standard of care) and by clinical symptoms.
- The diagnosis will be dissociated from hemianopia by perimetry. The hemispatial neglect consists of a lack of perception and responsiveness concerning the controlesional visual hemifield.
Patient with optic ataxia:
- After a stroke (> 1 month ago), presence of neurological injury in parietal cortex only, supported by a standard of care cerebral MRI
- Present optic ataxia symptoms (The OA consists of pointing errors with the hand contralateral to the lesion (hand effect) and / or to visual targets presented in the field contralateral to the lesion (field effect)).
Patient (adult and children) with attention-deficit hyperactivity disorder:
- present a diagnosis of ADHD subtype inattention or impulse / hyperactivity as established by a neuropsychologist.
- Children will be between 8 and 18 years old
- Adults will be between 18 and 75 years old.
- Participants will not report any comorbid learning disabilities to ADHD.
For minors:
- Having obtained the written consent of the legal representative(s)
Healthy subjects
Inclusion Criteria:
- no known neurological injury
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Healthy volunteers
|
The targets are presented to the subject on a computer screen.
The subject must make an eye or hand movement toward the target and ignore the distracters.
The targets are presented to the subject on a computer screen.
The subject must make an eye movement towards this target.
Sometimes a stop signal will appear and the subject will have to avoid to look at the target
The targets are presented to the subject on a computer screen.
The subject must make an eye movement toward this target.
Sometimes an instruction will ask the subject to look at the opposite of the target
|
Experimental: patients with optic ataxia (OA)
|
The targets are presented to the subject on a computer screen.
The subject must make an eye or hand movement toward the target and ignore the distracters.
The targets are presented to the subject on a computer screen.
The subject must make an eye movement towards this target.
Sometimes a stop signal will appear and the subject will have to avoid to look at the target
The targets are presented to the subject on a computer screen.
The subject must make an eye movement toward this target.
Sometimes an instruction will ask the subject to look at the opposite of the target
|
Experimental: patients with hemispatial neglect
|
The targets are presented to the subject on a computer screen.
The subject must make an eye or hand movement toward the target and ignore the distracters.
The targets are presented to the subject on a computer screen.
The subject must make an eye movement towards this target.
Sometimes a stop signal will appear and the subject will have to avoid to look at the target
The targets are presented to the subject on a computer screen.
The subject must make an eye movement toward this target.
Sometimes an instruction will ask the subject to look at the opposite of the target
|
Experimental: patients with attention-deficit hyperactivity disorder
|
The targets are presented to the subject on a computer screen.
The subject must make an eye or hand movement toward the target and ignore the distracters.
The targets are presented to the subject on a computer screen.
The subject must make an eye movement towards this target.
Sometimes a stop signal will appear and the subject will have to avoid to look at the target
The targets are presented to the subject on a computer screen.
The subject must make an eye movement toward this target.
Sometimes an instruction will ask the subject to look at the opposite of the target
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
error rate
Time Frame: at the end of the simulation passage, an average of 3 years
|
The investigator calculate the number of right and wrong answers (a correct answer is a saccade carried out when it is necessary and by reaching the target; a false answer is a saccade made at the wrong time and / or not reaching the target) to obtain the error rate.
|
at the end of the simulation passage, an average of 3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
reaction time
Time Frame: at the end of the simulation passage, an average of 3 years
|
The investigator measure the time it takes for the subject to respond (perform the eye saccade)
|
at the end of the simulation passage, an average of 3 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Laure PISELLA, Centre de recherche de Neurosciences de Lyon (CRNL)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 69HCL19_0728
- 2019-A03055-52 (Other Identifier: ID-RCB)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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.
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