Ignite Creation Date:
2025-12-26 @ 11:10 AM
Ignite Modification Date:
2025-12-31 @ 3:26 PM
Study NCT ID:
NCT04379128
Status:
UNKNOWN
Last Update Posted:
2020-05-07
First Post:
2020-04-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Attentional Impairment in People With Epilepsy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004827', 'term': 'Epilepsy'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-04-02', 'size': 512136, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-05-06T03:44', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 272}, 'targetDuration': '1 Day', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2020-05', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2025-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-05-06', 'studyFirstSubmitDate': '2020-04-27', 'studyFirstSubmitQcDate': '2020-05-06', 'lastUpdatePostDateStruct': {'date': '2020-05-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-05-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'digit span', 'timeFrame': '5 minutes', 'description': 'immediate memory task'}, {'measure': 'verbal fluency', 'timeFrame': '5 minutes', 'description': 'executive task'}, {'measure': 'incompatibility TAP subtest', 'timeFrame': '8 minutes', 'description': 'executive task'}, {'measure': 'flexibility TAP subtest', 'timeFrame': '8 minutes', 'description': 'executive task'}, {'measure': 'Neurological Disorders Depression Inventory for Epilepsy (NDDI-E)', 'timeFrame': '3 minutes', 'description': 'Depression scale score 0 to 24'}, {'measure': 'GENERALIZED ANXIETY DISORDER (GAD-7)', 'timeFrame': '3 minutes', 'description': 'ANXIETY scale score : 0 to 21'}], 'primaryOutcomes': [{'measure': 'd2-r', 'timeFrame': '10 minutes', 'description': 'selective attention task'}], 'secondaryOutcomes': [{'measure': 'sustained attention TAP Subtest', 'timeFrame': '15 minutes', 'description': 'Your task is to press the key as quickly as possible whenever two successive patterns have the same shape'}, {'measure': 'alertness attention TAP Subtest', 'timeFrame': '8 minutes', 'description': 'a cross appears on the screen. press the key when the cross appears'}, {'measure': 'divided attention TAP Subtest', 'timeFrame': '5 minutes', 'description': 'first task :a cross appears on the screen in which a varying number of crosses appear simultaneously. when four of these crosses form a square, then please press the key as quickly as possible.\n\nsecond task: in this task you will hear a high and a low tone in sequence. you must decide whether the same tone occurs twice in a row. Please press the key as quickly as possible.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Epilepsy']}, 'referencesModule': {'references': [{'pmid': '30826090', 'type': 'RESULT', 'citation': 'Brissart H, Forthoffer N, Maillard L. Attention disorders in adults with epilepsy. Determinants and therapeutic strategies. Rev Neurol (Paris). 2019 Mar;175(3):135-140. doi: 10.1016/j.neurol.2019.01.394. Epub 2019 Feb 28.'}]}, 'descriptionModule': {'briefSummary': 'Epilepsy is one of the most common chronic neurological conditions.It leads to cognitive impairment in 20-50% of patients with a structural form.\n\nIn comparison with seizures, these cognitive disorders are a major additional factor in occupational, social and family disability. They are particularly frequent (50%) in temporal epilepsies and preferably concern memory and language skills.\n\nThe cognitive consequences of epilepsy are therefore well described in the following areas: episodic memory, language, executive functions.\n\nConcerning attentional abilities, a recent review has highlighted the lack of work in this specific field in order to properly measure the prevalence and nature of attentional disorders in epileptic patients. Indeed, attentional abilities are often mentioned in studies, but attention is a complex domain defined by four modalities: alertness, selective attention, divided attention and sustained attention. No study systematically assesses all of these modalities.\n\nThe objective of this study is to evaluate the prevalence and nature of attentional disorders in epileptic patients compared to control subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'people with epilepsy versus normal control', 'healthyVolunteers': True, 'eligibilityCriteria': 'Patients:\n\nInclusion Criteria:\n\n* Patient with epilepsy, according to Fisher et al. (2005).\n* Patient with written informed consent\n* affiliation to a social security regime is compulsory\n* Individuals who have received full information about the organization of the research and have not objected to their participation and the use of their data.\n* Patient 18 years of age and older\n\nNormal controls:\n\nIndividuals who have received full information about the organization of the research and have not objected to their participation and the use of their data.\n\n* People 18 years of age and older\n* People with no neurological and/or psychiatric history\n\nExclusion Criteria:\n\nfor patients: with another progressive neurological condition for all People of full age who are subject to a legal protection measure or who are unable to express their consent People deprived of their liberty by a judicial or administrative decision People who regularly use psychoactive substances (cannabis, alcohol...)'}, 'identificationModule': {'nctId': 'NCT04379128', 'acronym': 'ETAPE', 'briefTitle': 'Attentional Impairment in People With Epilepsy', 'organization': {'class': 'OTHER', 'fullName': 'Central Hospital, Nancy, France'}, 'officialTitle': 'Attentional Impairment in People With Epilepsy', 'orgStudyIdInfo': {'id': '2019-A02748-49'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'patients with epilepsy', 'description': 'Attentional tasks : D2-R task and TAP battery (sustained attention, alertness, divided attention) executive task : digit span, incompatibility and flexibility task (TAP battery), verbal fluencies depression score (NDDI-E scale) and anxiety score (GAD-7 scale)', 'interventionNames': ['Other: Attentional tasks']}, {'label': 'Normal controls', 'description': 'Attentional tasks : D2-R task and TAP battery (sustained attention, alertness, divided attention) executive task : digit span, incompatibility and flexibility task (TAP battery), verbal fluencies depression score (NDDI-E scale) and anxiety score (GAD-7 scale)', 'interventionNames': ['Other: Attentional tasks']}], 'interventions': [{'name': 'Attentional tasks', 'type': 'OTHER', 'description': 'a neuropsychological assessment of attentional task, executive task and interview is proposed to patients or normal control', 'armGroupLabels': ['Normal controls', 'patients with epilepsy']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'helene BRISSART, Dr', 'role': 'CONTACT', 'email': 'h.brissart@chru-nancy.fr', 'phone': '383851689', 'phoneExt': '+33'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Central Hospital, Nancy, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}