- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02417558
Cognitive/Physical Computer-Game Blended Training With Personalized Brain Network Activation Technology for the Elderly (AlterniityAR)
Study to Evaluate the Effectiveness of Personalized Brain Network Activation Technology in a Cognitive/Physical Computer-Game Blended Training of Elderly (Alterniity AR)
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.
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / 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.
|
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:
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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).
|
Active cognitive training by use of the VideoGrade software by Aristotle University of Thessaloniki.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
baseline to 40 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical Fitness
Time Frame: 2 months / 6+2 months / 12+2 months
|
Physical capacity was measured by means of the Senior Fitness Test
|
2 months / 6+2 months / 12+2 months
|
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).
|
2 months / 6+2 months / 12+2 months
|
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).
|
2 months / 6+2 months / 12+2 months
|
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).
|
2 months / 6+2 months / 12+2 months
|
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
|
2 months / 6+2 months / 12+2 months
|
Instrumental Activities of daily living
Time Frame: 2 months / 6+2 months / 12+2 months
|
instrumental activities of daily living (IADL)
|
2 months / 6+2 months / 12+2 months
|
Depressive symptoms
Time Frame: 2 months / 6+2 months / 12+2 months
|
Geriatric Depression Scale (GDS)
|
2 months / 6+2 months / 12+2 months
|
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.
|
12 months
|
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
|
2 months / 6+2 months / 12+2 months
|
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
|
2 months / 6+2 months / 12+2 months
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Magda Tsolaki, PhD, GAADRD
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 84171-B
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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