Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT05768620
Status:
COMPLETED
Last Update Posted:
2023-11-27
First Post:
2023-02-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Active Navigation Training
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}, {'id': 'D065854', 'term': 'Spatial Navigation'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D013037', 'term': 'Spatial Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059552', 'term': 'Caves'}], 'ancestors': [{'id': 'D055593', 'term': 'Geological Phenomena'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D004777', 'term': 'Environment'}, {'id': 'D055669', 'term': 'Ecological and Environmental Phenomena'}, {'id': 'D001686', 'term': 'Biological Phenomena'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Proof-of-concept trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 32}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-24', 'studyFirstSubmitDate': '2023-02-22', 'studyFirstSubmitQcDate': '2023-03-03', 'lastUpdatePostDateStruct': {'date': '2023-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Corsi supra-span test', 'timeFrame': 'After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up', 'description': 'Scores range from 0 to 29.16, higher scores indicate better visuospatial learning'}, {'measure': 'Change in Manikin Test', 'timeFrame': 'After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up', 'description': 'Scores range from 0 to 1, higher scores indicate better visuospatial mental rotation'}], 'secondaryOutcomes': [{'measure': 'Trail-making test part A and B', 'timeFrame': 'After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up'}, {'measure': 'Raccontino (6 Dicembre) (immediate-delayed-forgetting)', 'timeFrame': 'After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up'}, {'measure': 'Mini-mental state examination', 'timeFrame': 'After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up'}, {'measure': 'Digit span forward', 'timeFrame': 'After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up'}, {'measure': 'Corsi Block Tapping', 'timeFrame': 'After 10 training sessions (3/4 weeks approx.) and after 3-month follow-up'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['virtual reality'], 'conditions': ['Mild Cognitive Impairment', 'Spatial Navigation']}, 'descriptionModule': {'briefSummary': 'Pilot testing and development of an immersive virtual reality system for spatial navigation training in mild cognitive impairment syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* clinical diagnosis of mild cognitive impairment\n* absence of severe cognitive deterioration as assessed by the Italian version of the MMSE (Magni et al. 1996)\n* age ≥ 60\n\nExclusion Criteria:\n\n* the presence of acute stroke/transient ischemic attack;\n* the presence of other concomitants severe neurological/psychiatric diseases;\n* history of traumatic brain injury with loss of consciousness;\n* physical/functional deficits that could affect the use of immersive virtual reality;\n* severe visual deficiency;\n* the presence of recurrent vertigo.'}, 'identificationModule': {'nctId': 'NCT05768620', 'acronym': 'ANTaging', 'briefTitle': 'Active Navigation Training', 'organization': {'class': 'OTHER', 'fullName': 'Istituto Auxologico Italiano'}, 'officialTitle': 'Active Navigation Training: an Innovative Embodied-based Training System for Spatial Navigation in Aging', 'orgStudyIdInfo': {'id': '39M801'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CAVE', 'description': '10 immersive virtual reality sessions to train spatial memory', 'interventionNames': ['Other: CAVE']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'TAU', 'description': '10 paper and pencil sessions to train spatial memory', 'interventionNames': ['Other: TAU']}], 'interventions': [{'name': 'CAVE', 'type': 'OTHER', 'description': 'The training is designed to train spatial navigation and memory and in particular egocentric and allocentric processes', 'armGroupLabels': ['CAVE']}, {'name': 'TAU', 'type': 'OTHER', 'description': 'This is the usual care used to train visuospatial processes', 'armGroupLabels': ['TAU']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20145', 'city': 'Milan', 'state': 'Lombardy', 'country': 'Italy', 'facility': 'Cosimo Tuena', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Istituto Auxologico Italiano', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}