Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2026-02-27 @ 10:33 AM
Study NCT ID:
NCT02417558
Status:
COMPLETED
Last Update Posted:
2022-02-08
First Post:
2015-03-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cognitive/Physical Computer-Game Blended Training With Personalized Brain Network Activation Technology for the Elderly
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 607}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-02', 'completionDateStruct': {'date': '2018-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-02-07', 'studyFirstSubmitDate': '2015-03-26', 'studyFirstSubmitQcDate': '2015-04-14', 'lastUpdatePostDateStruct': {'date': '2022-02-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Diagnostic Area Under the Receiver Operating Characteristic Curve (ROC-AUC)', 'timeFrame': 'baseline to 40 months', 'description': 'The Digital Neuro Signatures (DNS) score will be tested in this prospective cohort. Sensitivity, specificity and accuracy of the DNS score will be tested for detecting intervention responses for both the placebo and the study groups and will be compared to the intervention responses measured by the neuropsychological test battery.'}], 'secondaryOutcomes': [{'measure': 'Physical Fitness', 'timeFrame': '2 months / 6+2 months / 12+2 months', 'description': 'Physical capacity was measured by means of the Senior Fitness Test'}, {'measure': 'Episodic memory', 'timeFrame': '2 months / 6+2 months / 12+2 months', 'description': 'calculated by averaging z-standardized sub-scores of the three cognitive tests (CVLT, the Digit Span Test and TMT).'}, {'measure': 'Working Memory', 'timeFrame': '2 months / 6+2 months / 12+2 months', 'description': 'calculated by averaging z-standardized sub-scores of the three cognitive tests (CVLT, the Digit Span Test and TMT).'}, {'measure': 'Executive Function', 'timeFrame': '2 months / 6+2 months / 12+2 months', 'description': 'calculated by averaging z-standardized sub-scores of the three cognitive tests (CVLT, the Digit Span Test and TMT).'}, {'measure': 'World Health Organization Quality of Life (WHOQoL)', 'timeFrame': '2 months / 6+2 months / 12+2 months', 'description': 'The World Health Organization Quality of Life (WHOQOL-100) questionnaire is a generic quality of life (QoL) measurement tool used in various cultural and social settings and across different patient and healthy populations. It was developed collaboratively in 15 cultural settings over several years and has been field tested in 37 centres. It consists of 100-questions that has been translated into 29 languages. It yields a multi-dimensional profile of scores across domains and sub-domains (facets) of quality of life. More recently, the WHOQOL-BREF, an abbreviated 26 item version has been developed. Domains/dimensions 6: Physical, psychological, level of independence, social relationships, environment, spirituality/religion/personal beliefs'}, {'measure': 'Instrumental Activities of daily living', 'timeFrame': '2 months / 6+2 months / 12+2 months', 'description': 'instrumental activities of daily living (IADL)'}, {'measure': 'Depressive symptoms', 'timeFrame': '2 months / 6+2 months / 12+2 months', 'description': 'Geriatric Depression Scale (GDS)'}, {'measure': 'Overall brain function', 'timeFrame': '12 months', 'description': 'The paradigm for the current study will combine neurophysiological knowledge with mathematical signal processing and pattern recognition methods to temporally and spatially map brain function, connectivity and synchronization.'}, {'measure': 'Verbal learning and memory as assessed using California Verbal Learning Test (CVLT)', 'timeFrame': '2 months / 6+2 months / 12+2 months', 'description': 'California Verbal Learning Test (CVLT) used to assess verbal learning and memory'}, {'measure': 'Verbal short-term memory as assessed using the Digit Span Test', 'timeFrame': '2 months / 6+2 months / 12+2 months', 'description': 'Digit Span Test and the Trail Making Test (TMT) used to assess verbal short-term memory'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Mild Cognitive Impairment, So Stated', 'Mild Dementia', 'Healthy']}, 'referencesModule': {'references': [{'pmid': '10977568', 'type': 'BACKGROUND', 'citation': 'Tarnanas I. A virtual environment for the assessment and the rehabilitation of the visuo-constructional ability in dementia patients. Stud Health Technol Inform. 2000;70:341-3.'}, {'pmid': '25658491', 'type': 'BACKGROUND', 'citation': 'Tarnanas I, Schlee W, Tsolaki M, Muri R, Mosimann U, Nef T. Ecological validity of virtual reality daily living activities screening for early dementia: longitudinal study. JMIR Serious Games. 2013 Aug 6;1(1):e1. doi: 10.2196/games.2778.'}, {'pmid': '23147007', 'type': 'BACKGROUND', 'citation': 'Laskaris NA, Tarnanas I, Tsolaki MN, Vlaikidis N, Karlovasitou AK. Improved detection of amnestic MCI by means of discriminative vector quantization of single-trial cognitive ERP responses. J Neurosci Methods. 2013 Jan 30;212(2):344-54. doi: 10.1016/j.jneumeth.2012.10.014. Epub 2012 Nov 9.'}, {'pmid': '24656838', 'type': 'BACKGROUND', 'citation': "Tarnanas I, Tsolaki M, Nef T, M Muri R, Mosimann UP. Can a novel computerized cognitive screening test provide additional information for early detection of Alzheimer's disease? Alzheimers Dement. 2014 Nov;10(6):790-8. doi: 10.1016/j.jalz.2014.01.002. Epub 2014 Mar 18."}, {'pmid': '25416111', 'type': 'BACKGROUND', 'citation': 'Tarnanas I, Laskaris N, Tsolaki M, Muri R, Nef T, Mosimann UP. On the comparison of a novel serious game and electroencephalography biomarkers for early dementia screening. Adv Exp Med Biol. 2015;821:63-77. doi: 10.1007/978-3-319-08939-3_11.'}], 'seeAlsoLinks': [{'url': 'http://link.springer.com/chapter/10.1007/978-3-642-45432-5_4', 'label': 'Assessing Virtual Reality Environments as Cognitive Stimulation Method for Patients with Mild Cognitive Impairment (MCI)'}]}, 'descriptionModule': {'briefSummary': 'The study involves a novel Virtual Reality Interface that offers full-body immersion "Alterniity AR" and more specifically computer exercises blended with game activities. It was hypothesized that "Alterniity AR" facilitated, game blended cognitive and/or physical exercise improves global cognition when compared to control groups; moreover, these improvements may be manifested by brain activity changes. The investigators explore here the impact of potential moderators on combined exercise-induced cognitive benefits, as well as, individual/separate training schemes.\n\nIn addition, the proposed study will provide Alterniity AR" in a closed feedback loop with a direct, reliable, and non-invasive method for assessing changes in brain activity associated with elderly in risk of dementia. The paradigm for the current study will combine neurophysiological knowledge with mathematical signal processing and pattern recognition methods to temporally and spatially map brain function, connectivity and synchronization.', 'detailedDescription': 'Currently, there is no direct, reliable, bed-side, and non-invasive method for assessing changes in brain activity associated with elderly in risk of dementia. Event Related Potentials (ERPs), which are temporal reflections of the neural mass electrical activity of cells in specific regions of the brain that occur in response to stimuli, may offer such a method, as they provide both a noninvasive and portable measure of brain function. The ERPs provide excellent temporal information, but spatial resolution for ERPs has traditionally been limited. However, by using high-density electroencephalograph (EEG) recording spatial resolution for ERPs is improved significantly. The proposed study will provide additional evidence for the utility and contribution of a Personalized Brain Network Activation (PBNA) test (reflecting temporal and spatial changes in brain activity as well as brain functional connectivity associated with minor neurocognitive disorder) in early dementia management.\n\nThe study is conducted in 2 sites: Switzerland and Greece. It uses a pre-post-test design with the between-participant factor group \\[intervention(s) vs. passive and/or active control\\]. Post-test will be conducted within 2 weeks after completion of the exercise period. Interventions will be carried out within day care centres, hospitals, senior care centres, a memory outpatient centre, local parishes, and at participants\' homes. Centres will provide 8-12 exercise weeks per year for 3 years, with a frequency of at least 3 "Alterniity AR" sessions per week, resulting in at least 24-36 intervention sessions each year of the study. The closed feedback loop with a direct PBNA test is basically divided to 3 phases - first EEG data is collected from subjects using a portable EEG system while the participants are performing the "Alterniity AR" intervention. The EEG data is then analysed offline. Finally, the "Alterniity AR" exercise type, configuration and difficulty level is updated based on the analysed data.\n\nThe Greek site population (n=581) in majority subjects with mild cognitive impairment (MCI) has been described before with Clinical Trial Registration: NCT02313935\n\nThe Swiss population (n=126) was 20 healthy controls (HC), 20 mild to moderate Alzheimer\'s disease (AD) patients, 20 vascular dementia (VAD) patients, 20 fronto-temporal dementia (FTD) patients and 40 subjects with mild cognitive impairment (MCI). This population has been previously described at the following ClinicalTrials.gov Identifier: NCT02050464.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* no severe cognitive impairment measured by Mini-Mental State Examination (MMSE) ≥ 18\n* fluent language skills\n* agreement of a medical doctor\n* time commitment to the test and exercise protocol.\n\nExclusion Criteria:\n\n* concurrent participation in another study\n* severe physical or psychological disorders which precluded participation in the intervention (i.e., inability to follow instructions)\n* unrecovered neurological disorders such as stroke, traumatic brain injury, unstable medication within the past three months\n* severe and uncorrectable vision problems, or hearing aid for less than three months.'}, 'identificationModule': {'nctId': 'NCT02417558', 'acronym': 'AlterniityAR', 'briefTitle': 'Cognitive/Physical Computer-Game Blended Training With Personalized Brain Network Activation Technology for the Elderly', 'organization': {'class': 'INDUSTRY', 'fullName': 'XtremeVRI AG'}, 'officialTitle': 'Study to Evaluate the Effectiveness of Personalized Brain Network Activation Technology in a Cognitive/Physical Computer-Game Blended Training of Elderly (Alterniity AR)', 'orgStudyIdInfo': {'id': '84171-B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Alterniity Augmented Reality (AAR)', 'description': 'AAR training Participants use the patent pending AAR exercise and gaming (exergaming) platform that combines a physical training component (PTC) and a cognitive training component (CTC) in closed-feedback loop with Personalized Brain Network Activity (PBNA) test from a portable EEG.', 'interventionNames': ['Behavioral: Alterniity Augmented Reality (AAR)']}, {'type': 'NO_INTERVENTION', 'label': 'Passive Control Participants', 'description': 'Passive Control Participants do not receive an intervention serving as passive controls'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Active', 'description': 'Active Control Participants receive an alternative cognitive training scheme; software was built on purpose by the Aristotle University of Thessaloniki. The software is called VideoGrade and uses videos from Youtube (YouTube) documentaries (VideoGrade).', 'interventionNames': ['Behavioral: VideoGrade']}], 'interventions': [{'name': 'Alterniity Augmented Reality (AAR)', 'type': 'BEHAVIORAL', 'otherNames': ['VR-DOT', 'VPH-DARE@IT'], 'description': 'AAR is a patent pending exercise and gaming (exergaming) computer platform with a physical training component (PTC) and a cognitive training component (CTC). It fully immerses a user inside a virtual environment where he is practising complex everyday activities, such as going shopping, using the transportation, visiting a foreign city, eating at a restaurant, cooking dinner etc. His motor behaviour is monitored by means of motion capture, while immersed at this full-body immersion. In addition his cognition is monitored in real-time with Personalized Brain Network Activity (PBNA) screening. Both the motor and brain analyses are then used to update the configuration, type and difficulty of the AAR scenarios.', 'armGroupLabels': ['Alterniity Augmented Reality (AAR)']}, {'name': 'VideoGrade', 'type': 'BEHAVIORAL', 'description': 'Active cognitive training by use of the VideoGrade software by Aristotle University of Thessaloniki.', 'armGroupLabels': ['Active']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Magda Tsolaki, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'GAADRD'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'XtremeVRI AG', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Aristotle University Of Thessaloniki', 'class': 'OTHER'}, {'name': "Greek Alzheimer's Association and Related Disorders", 'class': 'OTHER'}, {'name': 'Klinik Hirslanden, Zurich', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}