Ignite Creation Date:
2025-12-24 @ 11:56 PM
Ignite Modification Date:
2026-03-27 @ 11:30 AM
Study NCT ID:
NCT01265251
Status:
COMPLETED
Last Update Posted:
2010-12-23
First Post:
2010-12-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Computerized Neuropsychology in Idiopathic Normal Pressure Hydrocephalus (INPH)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006850', 'term': 'Hydrocephalus, Normal Pressure'}, {'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D006849', 'term': 'Hydrocephalus'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 97}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-22', 'studyFirstSubmitDate': '2010-12-21', 'studyFirstSubmitQcDate': '2010-12-22', 'lastUpdatePostDateStruct': {'date': '2010-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Validity', 'timeFrame': 'Within 24 h', 'description': 'Computerized test battery and equivalent standard neuropsychological test battery is given to the same subject. Correlation between paper and pen and equivalent computerized test is calculated as a validity measure.'}, {'measure': 'Reliability', 'timeFrame': 'More than 7 days, within 2 months', 'description': 'The computerized test battery is given to the same subject twice. Correlation between the two tests is calculated as a test-retest reliability measure.'}, {'measure': 'Feasibility', 'timeFrame': 'Within 24 h', 'description': 'Patients under the investigation for INPH are given the computerized test battery. Number of patients who manage to complete the test is the feasibility measure.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Normal Pressure Hydrocephalus', 'Neuropsychological Test', 'Assessment of cognitive disorders/dementia', 'Neuropsychological assessment'], 'conditions': ['Normal Pressure Hydrocephalus']}, 'referencesModule': {'references': [{'pmid': '25279138', 'type': 'DERIVED', 'citation': 'Behrens A, Eklund A, Elgh E, Smith C, Williams MA, Malm J. A computerized neuropsychological test battery designed for idiopathic normal pressure hydrocephalus. Fluids Barriers CNS. 2014 Sep 25;11:22. doi: 10.1186/2045-8118-11-22. eCollection 2014.'}]}, 'descriptionModule': {'briefSummary': 'A computerised neuropsychological test battery to be used as a standardised tool assessing the cognitive domains affected by idiopathic normal pressure hydrocephalus INPH was developed. The aim of this study is to investigate the reliability, validity and feasibility of the battery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Reliability: Healthy elderly Validity: Various diseases Feasibility: Possible INPH-patients', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Probable INPH under investigation\n* Healthy elderly\n* Various diseases\n\nExclusion Criteria:\n\n* (Healthy elderly) medications affecting nervous system\n* (Healthy elderly)heart disease\n* (Healthy elderly)diabetes\n* (Healthy elderly)disease of the nervous system\n* (Healthy elderly)MMSE \\< 28\n* (Healthy elderly)vascular risk factors (Two of: 1 hypertension, 2 smoking or 3 hyperlipidemia)\n* (Healthy elderly)serious disease that may shorten life expectancy\n* (Various diseases) Affected motor functions'}, 'identificationModule': {'nctId': 'NCT01265251', 'briefTitle': 'Computerized Neuropsychology in Idiopathic Normal Pressure Hydrocephalus (INPH)', 'organization': {'class': 'OTHER', 'fullName': 'Umeå University'}, 'officialTitle': 'Evaluation of a Computerised Neuropsychological Test Battery for Idiopathic Normal Pressure Hydrocephalus (INPH)', 'orgStudyIdInfo': {'id': '07-088M'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Test-retest', 'description': 'Forty-four healthy elderly 60-82 years old', 'interventionNames': ['Device: Computerized neuropsychological test']}, {'label': 'Validity', 'description': 'Twenty six patients with various diseases and various ages', 'interventionNames': ['Device: Computerized neuropsychological test', 'Other: Conventional neuropsychological test']}, {'label': 'Feasibility', 'description': 'Twenty seven patients under the preoperative investigation for INPH', 'interventionNames': ['Device: Computerized neuropsychological test']}], 'interventions': [{'name': 'Computerized neuropsychological test', 'type': 'DEVICE', 'description': 'Computerized neuropsychological test battery.', 'armGroupLabels': ['Feasibility', 'Test-retest', 'Validity']}, {'name': 'Conventional neuropsychological test', 'type': 'OTHER', 'description': 'Conventional neuropsychological test (paper and pen)', 'armGroupLabels': ['Validity']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'SE-901 85', 'city': 'Umeå', 'state': 'Västerbotten County', 'country': 'Sweden', 'facility': 'Department of Clinical Neuroscience', 'geoPoint': {'lat': 63.82842, 'lon': 20.25972}}], 'overallOfficials': [{'name': 'Anders Behrens, M.D., M.Sc.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Clinical Neuroscience'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Umeå University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Anders Behrens M.D.', 'oldOrganization': 'Department of Clinical Neuroscience'}}}}