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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02417558
Recruitment Status : Completed
First Posted : April 15, 2015
Last Update Posted : February 8, 2022
Sponsor:
Collaborators:
Aristotle University Of Thessaloniki
Greek Alzheimer's Association and Related Disorders
Klinik Hirslanden, Zurich
Information provided by (Responsible Party):
XtremeVRI AG

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
Mild Cognitive Impairment, So Stated Mild Dementia Healthy Behavioral: Alterniity Augmented Reality (AAR) Behavioral: VideoGrade Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : February 2015
Actual Primary Completion Date : September 2018
Actual Study Completion Date : December 2018

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.




Primary Outcome Measures :
  1. Change in Diagnostic Area Under the Receiver Operating Characteristic Curve (ROC-AUC) [ Time Frame: 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 [ Time Frame: 2 months / 6+2 months / 12+2 months ]
    Physical capacity was measured by means of the Senior Fitness Test

  2. Episodic memory [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 2 months / 6+2 months / 12+2 months ]
    instrumental activities of daily living (IADL)

  7. Depressive symptoms [ Time Frame: 2 months / 6+2 months / 12+2 months ]
    Geriatric Depression Scale (GDS)

  8. Overall brain function [ Time Frame: 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) [ Time Frame: 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 [ Time Frame: 2 months / 6+2 months / 12+2 months ]
    Digit Span Test and the Trail Making Test (TMT) used to assess verbal short-term memory



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02417558


Sponsors and Collaborators
XtremeVRI AG
Aristotle University Of Thessaloniki
Greek Alzheimer's Association and Related Disorders
Klinik Hirslanden, Zurich
Investigators
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Study Director: Magda Tsolaki, PhD GAADRD
Additional Information:
Publications:
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Responsible Party: XtremeVRI AG
ClinicalTrials.gov Identifier: NCT02417558    
Other Study ID Numbers: 84171-B
First Posted: April 15, 2015    Key Record Dates
Last Update Posted: February 8, 2022
Last Verified: February 2022
Additional relevant MeSH terms:
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Cognitive Dysfunction
Neurocognitive Disorders
Mental Disorders
Cognition Disorders