Ignite Creation Date:
2025-12-24 @ 11:31 PM
Ignite Modification Date:
2025-12-25 @ 9:19 PM
Study NCT ID:
NCT05785156
Status:
UNKNOWN
Last Update Posted:
2023-03-27
First Post:
2023-03-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Diagnostic and Prognostic Value of New Quick Tests of Action Slowing in Stroke and in Cognitive Neurodegenerative Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020521', 'term': 'Stroke'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D004194', 'term': 'Disease'}, {'id': 'D006967', 'term': 'Hypersensitivity'}], 'ancestors': [{'id': 'D002561', 'term': 'Cerebrovascular Disorders'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 129}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2025-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-03-14', 'studyFirstSubmitDate': '2023-03-14', 'studyFirstSubmitQcDate': '2023-03-14', 'lastUpdatePostDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Value of the speed of the action with the 'RT Componential Analysis of Action Speed' battery in all patients", 'timeFrame': '12 months', 'description': 'RT Componential Analysis of Action Speed'}], 'secondaryOutcomes': [{'measure': 'Speed values of action measured in all patients with the "MindPlus" battery in all patients', 'timeFrame': '12 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['executive processes', 'attention', 'Stroke', 'action speed', 'Diagnostic', 'sensitivity', 'specificity', 'dementia mild cognitive impairment', 'Alzheimer disease'], 'conditions': ['Stroke', 'Action Speed', 'Dementia Mild Cognitive Impairment', 'Alzheimer Disease']}, 'descriptionModule': {'briefSummary': 'A large series of recent studies have documented the frequency of the slowing of the action in brain diseases, especially vascular and neurodegenerative diseases. In stroke, the predictive value of action slowing at the acute phase for predicting post-stroke functional outcome remains poorly investigated. In neurodegenerative diseases, the diagnostic relevance of the slowing at the prodromal stage remains unknown and this diagnostic requires new tests. Finally, in terms of anatomical determinants, few studies have studied the determinants of action slowing. The objectives of this project are to Determine the diagnostic and prognostic value of action slowing assessed with new quick tests in patients with acute stroke (Neurovascular Unit) and cognitive neurodegenerative disorders (Alzheimer Disease (AD), Lewy Body disease (LBD), Fronto Temporal lobar degeneration (FTLD), Cortico Basal Degeneration (CBD) and Progressive Supra Nuclear Palsy (PSNP)) and to define the lesion determinants with VBM and VLSM'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'acute stroke patients (Stroke Unit) and cognitive neurodegenerative disorder patients (Alzheimer Disease (AD), Lewy Body diseaese (LBD), FrontoTemporal lobar degeneration (FTLD), Cortico Basal Degeneration (CBD) and Progressive SupraNuclear Palsy (PSNP))', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patients between 40 and 85 years old,\n* French native language,\n* Social Security affiliation.\n* University Memory Clinic for: Mild severity disorder (MMSE\\> 19) or major severity disorder related to AD : Albert 2011 criteria ; McKhann 2011\n* to MCL according to McKeith criteria\n* to FTLD according to Rascovsky 2011 criteria\n* BBD according to Armstrong's criteria\n* related to PSP according to Höglinger criteria\n\nExclusion Criteria:\n\n* Mental retardation or guardianship\n* Previously diagnosed dementia\n* Other current or past brain condition\n* severe head trauma\n* epilepsy prior to stroke still requiring previous treatment\n* Parkinson disease, multiple sclerosis...\n* brain tumor or brain radiation therapy\n* Current or past schizophrenia or psychosis\n* Active or past psychiatric disorders requiring a stay\\> 2 days in a specialized environment\n* Contra indication to MRI\n* Comorbidity with life expectancy \\<1 year\n* Comorbidity affecting cognition in particular:\n* Alcohol (\\> 3 glasses / day) or history of alcohol withdrawal syndrome\n* opiate or cocaine addiction or opiate withdrawal syndrome\n* renal failure (dialysis or creatinine clearance \\<30)\n* hepatic failure (spontaneous INR\\> 1.5 or PT \\<60%)\n* respiratory failure requiring oxygen therapy\n* heart failure (orthopnea\\> 2 pillows)\n* persistent vigilance disturbances (NIHSS1a score ≤1)\n* cancer with paraneoplastic syndrome\n* treatment with gold salts, D Penicillamine or other treatment with cognitive effect\n* Patient under guardianship or curators or private under public law\n* Pregnant and / or lactating wom"}, 'identificationModule': {'nctId': 'NCT05785156', 'acronym': 'QTOAS', 'briefTitle': 'Diagnostic and Prognostic Value of New Quick Tests of Action Slowing in Stroke and in Cognitive Neurodegenerative Disease', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire, Amiens'}, 'officialTitle': 'Diagnostic and Prognostic Value of New Quick Tests of Action Slowing in Stroke and in Cognitive Neurodegenerative Disease', 'orgStudyIdInfo': {'id': 'PI2021_843_0082'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'acute stroke patients', 'interventionNames': ['Other: quick tests']}, {'label': 'cognitive neurodegenerative disorders', 'description': 'cognitive neurodegenerative disorders (Alzheimer Disease (AD), Lewy Body disease (LBD), FrontoTemporal lobar degeneration (FTLD), Cortico Basal Degeneration (CBD) and Progressive Supra Nuclear Palsy (PSNP)', 'interventionNames': ['Other: quick tests']}], 'interventions': [{'name': 'quick tests', 'type': 'OTHER', 'description': 'New quick tests are\n\n* Batterie MindPlus (Brevet n° FR1908081, Suarez 2019) is a quick reaction time battery and\n* Minimal Cognitive Evaluation (MCE) test (Sardi et al, 2019) is a cognitive screening tests including a specific assessment of slowing', 'armGroupLabels': ['acute stroke patients', 'cognitive neurodegenerative disorders']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80054', 'city': 'Amiens', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Martine Roussel, PhD', 'role': 'CONTACT', 'email': 'roussel.martine@chu-amiens.fr', 'phone': '0322667813'}, {'name': 'Olivier GODEFROY, Pr', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CHU Amiens', 'geoPoint': {'lat': 49.9, 'lon': 2.3}}], 'centralContacts': [{'name': 'Martine ROUSSEL, PhD', 'role': 'CONTACT', 'email': 'roussel.martine@chu-amiens.fr', 'phone': '0322667813'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire, Amiens', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}