Ignite Creation Date:
2025-12-24 @ 11:20 PM
Ignite Modification Date:
2025-12-25 @ 9:03 PM
Study NCT ID:
NCT04768556
Status:
RECRUITING
Last Update Posted:
2024-05-09
First Post:
2021-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Brain Activity Associated With Inhibition of Action in Attention-deficit
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001289', 'term': 'Attention Deficit Disorder with Hyperactivity'}], 'ancestors': [{'id': 'D019958', 'term': 'Attention Deficit and Disruptive Behavior Disorders'}, {'id': 'D065886', 'term': 'Neurodevelopmental Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study is pathophysiological, monocentric, comparative, and controlled with 3 groups compared: ADHD patients, control patients (negative diagnosis of ADHD), and healthy volunteers.\n\nThe three groups will complete the same protocol, in the same manner.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-05-08', 'studyFirstSubmitDate': '2021-02-05', 'studyFirstSubmitQcDate': '2021-02-23', 'lastUpdatePostDateStruct': {'date': '2024-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'EEG correlates of inhibition', 'timeFrame': '2 weeks', 'description': 'The main objective of this study is to evaluate, by electrophysiological measures, the presence of a deficit of action inhibition in adults with ADHD. To this end, the EEG correlates of inhibition will be compared between participants in the three groups. Thus, the ERP (N2 / P3) and ERSP (Theta, Delta) variations observed in terms of amplitude and latency in the stop-signal task tests will be computed in each of the three groups.'}], 'secondaryOutcomes': [{'measure': 'Inhibition performance from a rhythmic-action task', 'timeFrame': '2 weeks', 'description': "The inhibition performance from a rhythmic-action task, expressed as stop-signal reaction time (SSRT, in ms). This latency is measured by identifying a statistical deviation evoked by the STOP signal in the participants' movement on a graphic tablet (following the procedure described in Hervault et al., 2019)."}, {'measure': 'Inhibition performance from a discrete-action task', 'timeFrame': '2 weeks', 'description': 'The inhibition performance from a discrete-action task, expressed as an SSRT (in ms). According to the horse-race model of inhibition, this latency is estimated based on the response time and the response probability obtained by the participants when responding to the GO and STOP stimuli used in the task (following recent guidelines from Verbruggen et al., 2019).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['KEYWORDS: Inhibitory control', 'time-frequency'], 'conditions': ['Attention Deficit', 'Hyperactivity Disorder']}, 'descriptionModule': {'briefSummary': 'Inhibitory control allows individuals to suppress unwanted actions and to resist irrelevant stimuli. It is thought to be a core deficit in Attention-deficit/hyperactivity disorder (ADHD). The present study aims at evaluating this deficit in adults with ADHD. Executive and inhibitory capacities, as well as the neural mechanisms underlying inhibitory control, will be assessed in adults with ADHD and two control groups of participants.', 'detailedDescription': 'ADHD is a psychiatric disorder characterized by symptoms of inattention, hyperactivity, and impulsivity (DSM-V, 2013). An impairment of inhibitory control has been suggested as the primary deficit in children with ADHD, which is thought to cause secondary impairments in executive functioning. A few studies investigated executive capacities in adults with ADHD. Specifically, an impairment in action inhibition has been reported in ADHD participants. Moreover, inhibition of action is often associated with distinctive electroencephalographic (EEG) correlates. The present study aim at combining both novel inhibitory control measurement techniques and EEG analysis in temporal and frequency domains to assess the sensitivity and the specificity of an inhibitory deficit in adults with ADHD. This is part of an improvement in the procedures for diagnosing ADHD syndrome and its functional evaluation.\n\nThe study will analyze the EEG activity associated with two stop-signal tasks requiring inhibitory capacities. A set of other cognitive skills will also be evaluated during a neuropsychological assessment. The results of ADHD patients will be compared with those of a control group (healthy volunteers) to assess the sensitivity of an inhibition deficit to the disorder. These same results will also be compared with those of a second control group (patients with a negative diagnosis of ADHD) to assess the specificity of the inhibitory deficit.\n\nThis experimental strategy results in the involvement of three groups of participants (ADHD patients and two control groups) in three visits (neuropsychological assessment and two EEG sessions).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age between 18 and 50,\n\n * Visual, auditory (authorized apparatus), motor skills suitable for the proper realization of neuropsychological tests,\n * Being right-handed,\n * Free, informed and written consent signed by the participant and the investigator\n * Person affiliated or beneficiary of a social security scheme.\n* For the ADHD group:\n\n * Diagnosis of ADHD according to DSM-V criteria (APA, 2013),\n\nFor the patient control group:\n\n• Patient who consulted for a cognitive complaint and for whom the diagnosis of ADHD was rejected according to the criteria of DSM-V (APA, 2013).\n\nExclusion Criteria:\n\n* General or progressive neurological disease resulting in cognitive impairment (multiple sclerosis, Parkinson's disease, stroke, etc.),\n* Insufficient linguistic level in French to participate in neuropsychological assessment,\n* Patient placed under judicial protection or under another protective regime,\n* Severe depression according to DSM-V criteria (APA, 2013),\n* Autism spectrum disorder, developmental coordination disorder.\n\n -For the healthy voluntary control group:\n* Presence of a cognitive complaint or pathology which may impair his cognitive functions"}, 'identificationModule': {'nctId': 'NCT04768556', 'acronym': "INHIB'MOV", 'briefTitle': 'Brain Activity Associated With Inhibition of Action in Attention-deficit', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Toulouse'}, 'officialTitle': 'Assessment of Brain Activity Associated With Inhibition of Action in Attention-deficit Hyperactivity Disorder', 'orgStudyIdInfo': {'id': 'RC31/20/0252'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ADHD group', 'description': 'ADHD group: 20 participants having received a positive diagnosis of ADHD', 'interventionNames': ['Other: EEG experimental sessions 1', 'Other: EEG experimental sessions 2']}, {'type': 'OTHER', 'label': 'Control group 1', 'description': 'Control group 1: 20 participants having received a negative diagnosis of ADHD', 'interventionNames': ['Other: EEG experimental sessions 1', 'Other: EEG experimental sessions 2']}, {'type': 'OTHER', 'label': 'Control group 2', 'description': 'Control group 2: 20 participants as healthy volunteers', 'interventionNames': ['Other: EEG experimental sessions 1', 'Other: EEG experimental sessions 2']}], 'interventions': [{'name': 'EEG experimental sessions 1', 'type': 'OTHER', 'description': 'An EEG experimentation session on the stop-signal task of inhibiting a prepared discrete graphic action.', 'armGroupLabels': ['ADHD group', 'Control group 1', 'Control group 2']}, {'name': 'EEG experimental sessions 2', 'type': 'OTHER', 'description': 'An EEG experimentation session on the stop-signal task of inhibiting an ongoing rhythmic action', 'armGroupLabels': ['ADHD group', 'Control group 1', 'Control group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '31000', 'city': 'Toulouse', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jeremie PARIENTE, MD PHD', 'role': 'CONTACT', 'email': 'pariente.j@chu-toulouse.fr', 'phone': '0561779502'}], 'facility': 'Toulouse Purpan University Hospital', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}], 'centralContacts': [{'name': 'Jeremie PARIENTE, MD PHD', 'role': 'CONTACT', 'email': 'pariente.j@chu-toulouse.fr', 'phone': '05.61.77.95.02'}, {'name': 'Mario Hervaul, MS', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Jeremie PARIENTE, MD PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital, Toulouse'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Toulouse', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre National de la Recherche Scientifique, France', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}