Ignite Creation Date:
2025-12-25 @ 12:02 AM
Ignite Modification Date:
2025-12-25 @ 10:00 PM
Study NCT ID:
NCT04279158
Status:
RECRUITING
Last Update Posted:
2025-11-26
First Post:
2020-02-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Attention Modulation of Local and Global Inhibition Mechanisms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}, {'id': 'D007266', 'term': 'Inhibition, Psychological'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-11-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2031-11-26', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-19', 'studyFirstSubmitDate': '2020-02-11', 'studyFirstSubmitQcDate': '2020-02-19', 'lastUpdatePostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2020-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-11-26', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'error rate', 'timeFrame': 'at the end of the simulation passage, an average of 3 years', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'reaction time', 'timeFrame': 'at the end of the simulation passage, an average of 3 years', 'description': 'The investigator measure the time it takes for the subject to respond (perform the eye saccade)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['attention-deficit hyperactivity disorder (ADHD)', 'Attention Deficit Disorder with Hyperactivity', 'attention', 'inhibition', 'Healthy Volunteers', 'Perceptual Disorders'], 'conditions': ['Optical Phenomena']}, 'descriptionModule': {'briefSummary': '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.\n\nPrevious 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.\n\nIn 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'All patients and healthy subjects:\n\nInclusion Criteria:\n\n* male and female, age from 18 to 75 years included\n* normal vision or corrected vision\n* covered by social security\n* signed written informed consent\n\nExclusion Criteria:\n\n* unable to comply with requirements of the study (neurological, psychiatric, sensory or motor troubles)\n* adults under legal protection\n\nPatient with hemispatial neglect:\n\nInclusion Criteria:\n\n* After a stroke (\\> 1 month ago), presence of a neurological impairment documented by brain imaging (standard of care) and by clinical symptoms.\n* 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.\n\nPatient with optic ataxia:\n\n* After a stroke (\\> 1 month ago), presence of neurological injury in parietal cortex only, supported by a standard of care cerebral MRI\n* 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)).\n\nPatient (adult and children) with attention-deficit hyperactivity disorder:\n\n* present a diagnosis of ADHD subtype inattention or impulse / hyperactivity as established by a neuropsychologist.\n* Children will be between 8 and 18 years old\n* Adults will be between 18 and 75 years old.\n* Participants will not report any comorbid learning disabilities to ADHD.\n\nFor minors:\n\n\\- Having obtained the written consent of the legal representative(s)\n\nHealthy subjects\n\nInclusion Criteria:\n\n\\- no known neurological injury'}, 'identificationModule': {'nctId': 'NCT04279158', 'acronym': 'MILGattention', 'briefTitle': 'Attention Modulation of Local and Global Inhibition Mechanisms', 'organization': {'class': 'OTHER', 'fullName': 'Hospices Civils de Lyon'}, 'officialTitle': 'Attention Modulation of Local and Global Inhibition Mechanisms', 'orgStudyIdInfo': {'id': '69HCL19_0728'}, 'secondaryIdInfos': [{'id': '2019-A03055-52', 'type': 'OTHER', 'domain': 'ID-RCB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patients with optic ataxia (OA)', 'interventionNames': ['Behavioral: experience 1 "The negative priming task"', 'Behavioral: experience 2 "Stop signal task"', 'Behavioral: experience 3 "Anti-saccades"']}, {'type': 'EXPERIMENTAL', 'label': 'patients with hemispatial neglect', 'interventionNames': ['Behavioral: experience 1 "The negative priming task"', 'Behavioral: experience 2 "Stop signal task"', 'Behavioral: experience 3 "Anti-saccades"']}, {'type': 'EXPERIMENTAL', 'label': 'patients with attention-deficit hyperactivity disorder', 'interventionNames': ['Behavioral: experience 1 "The negative priming task"', 'Behavioral: experience 2 "Stop signal task"', 'Behavioral: experience 3 "Anti-saccades"']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Healthy volunteers', 'interventionNames': ['Behavioral: experience 1 "The negative priming task"', 'Behavioral: experience 2 "Stop signal task"', 'Behavioral: experience 3 "Anti-saccades"']}], 'interventions': [{'name': 'experience 1 "The negative priming task"', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Healthy volunteers', 'patients with attention-deficit hyperactivity disorder', 'patients with hemispatial neglect', 'patients with optic ataxia (OA)']}, {'name': 'experience 2 "Stop signal task"', 'type': 'BEHAVIORAL', 'description': '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', 'armGroupLabels': ['Healthy volunteers', 'patients with attention-deficit hyperactivity disorder', 'patients with hemispatial neglect', 'patients with optic ataxia (OA)']}, {'name': 'experience 3 "Anti-saccades"', 'type': 'BEHAVIORAL', 'description': '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', 'armGroupLabels': ['Healthy volunteers', 'patients with attention-deficit hyperactivity disorder', 'patients with hemispatial neglect', 'patients with optic ataxia (OA)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '69500', 'city': 'Bron', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'laure PISELLA, PhD', 'role': 'CONTACT', 'email': 'laure.pisella@inserm.fr', 'phone': '4 72 91 34 05', 'phoneExt': '+33'}, {'name': 'Julie OUERFELLI-ETHIER', 'role': 'CONTACT', 'email': 'julie.ouerfelli-ethier@inserm.fr'}, {'name': 'laure PISELLA, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Centre de Recherche en Neuroscience de Lyon', 'geoPoint': {'lat': 45.73865, 'lon': 4.91303}}], 'centralContacts': [{'name': 'Laure PISELLA, PhD', 'role': 'CONTACT', 'email': 'laure.pisella@inserm.fr', 'phone': '4 72 91 34 05', 'phoneExt': '+33'}, {'name': 'Julie OUERFELLI-ETHIER', 'role': 'CONTACT', 'email': 'julie.ouerfelli-ethier@inserm.fr'}], 'overallOfficials': [{'name': 'Laure PISELLA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre de recherche de Neurosciences de Lyon (CRNL)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospices Civils de Lyon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}