AlterniityAR: Cognitive/Physical Computer-Game Blended Training With Personalized Brain Network Activation Technology for the Elderly

Sponsor
XtremeVRI AG (Industry)
Overall Status
Completed
CT.gov ID
NCT02417558
Collaborator
Aristotle University Of Thessaloniki (Other), Greek Alzheimer's Association and Related Disorders (Other), Klinik Hirslanden, Zurich (Other)
607
3
46

Study Details

Study Description

Brief Summary

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.

In 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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Alterniity Augmented Reality (AAR)
  • Behavioral: VideoGrade
N/A

Detailed Description

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.

The 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.

The Greek site population (n=581) in majority subjects with mild cognitive impairment (MCI) has been described before with Clinical Trial Registration: NCT02313935

The 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.

Study Design

Study Type:
Interventional
Actual Enrollment :
607 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Study to Evaluate the Effectiveness of Personalized Brain Network Activation Technology in a Cognitive/Physical Computer-Game Blended Training of Elderly (Alterniity AR)
Study Start Date :
Feb 1, 2015
Actual Primary Completion Date :
Sep 1, 2018
Actual Study Completion Date :
Dec 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Alterniity Augmented Reality (AAR)

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.

Behavioral: Alterniity Augmented Reality (AAR)
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.
Other Names:
  • VR-DOT
  • VPH-DARE@IT
  • No Intervention: Passive Control Participants

    Passive Control Participants do not receive an intervention serving as passive controls

    Active Comparator: Active

    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).

    Behavioral: VideoGrade
    Active cognitive training by use of the VideoGrade software by Aristotle University of Thessaloniki.

    Outcome Measures

    Primary Outcome Measures

    1. Change in Diagnostic Area Under the Receiver Operating Characteristic Curve (ROC-AUC) [baseline to 40 months]

      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.

    Secondary Outcome Measures

    1. Physical Fitness [2 months / 6+2 months / 12+2 months]

      Physical capacity was measured by means of the Senior Fitness Test

    2. Episodic memory [2 months / 6+2 months / 12+2 months]

      calculated by averaging z-standardized sub-scores of the three cognitive tests (CVLT, the Digit Span Test and TMT).

    3. Working Memory [2 months / 6+2 months / 12+2 months]

      calculated by averaging z-standardized sub-scores of the three cognitive tests (CVLT, the Digit Span Test and TMT).

    4. Executive Function [2 months / 6+2 months / 12+2 months]

      calculated by averaging z-standardized sub-scores of the three cognitive tests (CVLT, the Digit Span Test and TMT).

    5. World Health Organization Quality of Life (WHOQoL) [2 months / 6+2 months / 12+2 months]

      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

    6. Instrumental Activities of daily living [2 months / 6+2 months / 12+2 months]

      instrumental activities of daily living (IADL)

    7. Depressive symptoms [2 months / 6+2 months / 12+2 months]

      Geriatric Depression Scale (GDS)

    8. Overall brain function [12 months]

      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.

    9. Verbal learning and memory as assessed using California Verbal Learning Test (CVLT) [2 months / 6+2 months / 12+2 months]

      California Verbal Learning Test (CVLT) used to assess verbal learning and memory

    10. Verbal short-term memory as assessed using the Digit Span Test [2 months / 6+2 months / 12+2 months]

      Digit Span Test and the Trail Making Test (TMT) used to assess verbal short-term memory

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • no severe cognitive impairment measured by Mini-Mental State Examination (MMSE) ≥ 18

    • fluent language skills

    • agreement of a medical doctor

    • time commitment to the test and exercise protocol.

    Exclusion Criteria:
    • concurrent participation in another study

    • severe physical or psychological disorders which precluded participation in the intervention (i.e., inability to follow instructions)

    • unrecovered neurological disorders such as stroke, traumatic brain injury, unstable medication within the past three months

    • severe and uncorrectable vision problems, or hearing aid for less than three months.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • XtremeVRI AG
    • Aristotle University Of Thessaloniki
    • Greek Alzheimer's Association and Related Disorders
    • Klinik Hirslanden, Zurich

    Investigators

    • Study Director: Magda Tsolaki, PhD, GAADRD

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    XtremeVRI AG
    ClinicalTrials.gov Identifier:
    NCT02417558
    Other Study ID Numbers:
    • 84171-B
    First Posted:
    Apr 15, 2015
    Last Update Posted:
    Feb 8, 2022
    Last Verified:
    Feb 1, 2022
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Feb 8, 2022