Mild Cognitive Impairment, So StatedAlterniityARNCT02417558
Cognitive/Physical Computer-Game Blended Training With Personalized Brain Network Activation Technology for the Elderly
A study testing Alterniity Augmented Reality (AAR) and VideoGrade in people with Mild Cognitive Impairment, So Stated and Mild Dementia, run by XtremeVRI AG.
Trial 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… Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mild Cognitive Impairment, So Stated, Mild Dementia, Healthy
- What is being tested?
- Alterniity Augmented Reality (AAR) and VideoGrade
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 607 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Dec 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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)
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.
Read the 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.
- Conditions
- Mild Cognitive Impairment, So Stated, Mild Dementia, Healthy
- Being tested
- Alterniity Augmented Reality (AAR), VideoGrade
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alterniity Augmented Reality (AAR)Behavioural
Also called VR-DOT, VPH-DARE@IT
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.
VideoGradeBehavioural
Active cognitive training by use of the VideoGrade software by Aristotle University of Thessaloniki.
| Study group | Role | What they receive |
|---|---|---|
| Alterniity Augmented Reality (AAR) | Experimental | 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. Receives: Behavioral: Alterniity Augmented Reality (AAR) |
| Passive Control Participants | No intervention | Passive Control Participants do not receive an intervention serving as passive controls |
| Active | Active comparator | 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). Receives: Behavioral: VideoGrade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Diagnostic Area Under the Receiver Operating Characteristic Curve (ROC-AUC)
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.
Measured: baseline to 40 months
Secondary outcomes (10)
Physical Fitness
Physical capacity was measured by means of the Senior Fitness Test
Measured: 2 months / 6+2 months / 12+2 months
Episodic memory
calculated by averaging z-standardized sub-scores of the three cognitive tests (CVLT, the Digit Span Test and TMT).
Measured: 2 months / 6+2 months / 12+2 months
Working Memory
calculated by averaging z-standardized sub-scores of the three cognitive tests (CVLT, the Digit Span Test and TMT).
Measured: 2 months / 6+2 months / 12+2 months
Executive Function
calculated by averaging z-standardized sub-scores of the three cognitive tests (CVLT, the Digit Span Test and TMT).
Measured: 2 months / 6+2 months / 12+2 months
World Health Organization Quality of Life (WHOQoL)
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
Measured: 2 months / 6+2 months / 12+2 months
Instrumental Activities of daily living
instrumental activities of daily living (IADL)
Measured: 2 months / 6+2 months / 12+2 months
Depressive symptoms
Geriatric Depression Scale (GDS)
Measured: 2 months / 6+2 months / 12+2 months
Overall brain function
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.
Measured: 12 months
Verbal learning and memory as assessed using California Verbal Learning Test (CVLT)
California Verbal Learning Test (CVLT) used to assess verbal learning and memory
Measured: 2 months / 6+2 months / 12+2 months
Verbal short-term memory as assessed using the Digit Span Test
Digit Span Test and the Trail Making Test (TMT) used to assess verbal short-term memory
Measured: 2 months / 6+2 months / 12+2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2015 (estimated)
- Study startFeb 2015
- Primary completionSep 2018
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Mild Cognitive Impairment, So StatedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 607 participants (actual)
Sponsor and investigators
- Lead sponsor
- XtremeVRI AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Aristotle University Of Thessaloniki, Greek Alzheimer's Association and Related Disorders, Klinik Hirslanden, Zurich
- Responsible party
- Sponsor
- Investigators
- Magda Tsolaki, PhD, Study director, GAADRD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02417558
- Sponsor's protocol ID
- 84171-B
- Acronym
- AlterniityAR
- Status last verified
- Feb 2022
- First submitted
- 26 Mar 2015
- Last updated
- 8 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 10977568Tarnanas 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.
PubMed 25658491Laskaris 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.
PubMed 23147007Tarnanas 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.
PubMed 24656838Tarnanas 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.
PubMed 25416111
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT02417558
- Acronym / sponsor ID
- AlterniityAR / 84171-B
- Conditions
- Mild Cognitive Impairment, So Stated, Mild Dementia, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 607 participants (actual)
- Lead sponsor
- XtremeVRI AGIndustry (pharma, biotech, devices)
- Collaborators
- Aristotle University Of Thessaloniki, Greek Alzheimer's Association and Related Disorders, Klinik Hirslanden, Zurich
- Study start
- Feb 2015
- Primary completion
- Sep 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 15 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Alterniity Augmented Reality (AAR) | Experimental | Behavioral: 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. |
| Passive Control Participants | No intervention | –Passive Control Participants do not receive an intervention serving as passive controls |
| Active | Active comparator | Behavioral: VideoGradeActive 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). |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alterniity Augmented Reality (AAR)Also: VR-DOT, VPH-DARE@ITAAR 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. | Behavioural | Alterniity Augmented Reality (AAR) |
| VideoGradeActive cognitive training by use of the VideoGrade software by Aristotle University of Thessaloniki. | Behavioural | Active |
Primary outcome
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.
10 secondary outcomes
Physical Fitness
Time frame: 2 months / 6+2 months / 12+2 months
Episodic memory
Time frame: 2 months / 6+2 months / 12+2 months
Working Memory
Time frame: 2 months / 6+2 months / 12+2 months
Executive Function
Time frame: 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
Instrumental Activities of daily living
Time frame: 2 months / 6+2 months / 12+2 months
Depressive symptoms
Time frame: 2 months / 6+2 months / 12+2 months
Overall brain function
Time frame: 12 months
Verbal learning and memory as assessed using California Verbal Learning Test (CVLT)
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2022.
- Background: PubMed 10977568Tarnanas 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.
- Background: PubMed 25658491Tarnanas 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.
- Background: PubMed 23147007Laskaris 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.
- Background: PubMed 24656838Tarnanas 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.
- Background: PubMed 25416111Tarnanas 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.
- Assessing Virtual Reality Environments as Cognitive Stimulation Method for Patients with Mild Cognitive Impairment (MCI)Link provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magda Tsolaki, PhD study director
GAADRD
Questions about this trial
What is this clinical trial studying?
A study testing Alterniity Augmented Reality (AAR) and VideoGrade in people with Mild Cognitive Impairment, So Stated and Mild Dementia, run by XtremeVRI AG.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Diagnostic Area Under the Receiver Operating Characteristic Curve (ROC-AUC) (time frame: baseline to 40 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02417558, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2022.