Clinical trial NCT02417558: Cognitive/Physical Computer-Game Blended Training With Personalized Brain Network Activation Technology for the Elderly
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Cognitive Impairment, So Stated
Mild Dementia
Healthy
Lead sponsor: XtremeVRI AG
Sponsor class: INDUSTRY
Collaborators: name: Aristotle University Of Thessaloniki
name: Greek Alzheimer's Association and Related Disorders
name: Klinik Hirslanden, Zurich
First posted: 2015-04-15
Enrollment: 607
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility 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.

Primary outcomes:
measure: Change in Diagnostic Area Under the Receiver Operating Characteristic Curve (ROC-AUC)
timeFrame: baseline to 40 months
Secondary outcomes:
measure: Physical Fitness
timeFrame: 2 months / 6+2 months / 12+2 months
measure: Episodic memory
timeFrame: 2 months / 6+2 months / 12+2 months
measure: Working Memory
timeFrame: 2 months / 6+2 months / 12+2 months
measure: Executive Function
timeFrame: 2 months / 6+2 months / 12+2 months
measure: World Health Organization Quality of Life (WHOQoL)
timeFrame: 2 months / 6+2 months / 12+2 months
measure: Instrumental Activities of daily living
timeFrame: 2 months / 6+2 months / 12+2 months
measure: Depressive symptoms
timeFrame: 2 months / 6+2 months / 12+2 months
measure: Overall brain function
timeFrame: 12 months
measure: Verbal learning and memory as assessed using California Verbal Learning Test (CVLT)
timeFrame: 2 months / 6+2 months / 12+2 months
measure: Verbal short-term memory as assessed using the Digit Span Test
timeFrame: 2 months / 6+2 months / 12+2 months
Other outcomes:
Locations:
Study officials:
affiliation: GAADRD
name: Magda Tsolaki, PhD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.