NCT02417558

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
607

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2015

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2015

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 26, 2015

Completed
20 days until next milestone

First Posted

Study publicly available on registry

April 15, 2015

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

February 8, 2022

Status Verified

February 1, 2022

Enrollment Period

3.6 years

First QC Date

March 26, 2015

Last Update Submit

February 7, 2022

Conditions

Mild Cognitive Impairment, So StatedMild DementiaHealthy

Outcome Measures

Primary Outcomes (1)

  • 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.

    baseline to 40 months

Secondary Outcomes (10)

  • Physical Fitness

    2 months / 6+2 months / 12+2 months

  • Episodic memory

    2 months / 6+2 months / 12+2 months

  • Working Memory

    2 months / 6+2 months / 12+2 months

  • Executive Function

    2 months / 6+2 months / 12+2 months

  • World Health Organization Quality of Life (WHOQoL)

    2 months / 6+2 months / 12+2 months

  • +5 more secondary outcomes

Study Arms (3)

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.

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).

Behavioral: VideoGrade

Interventions

Alterniity Augmented Reality (AAR)BEHAVIORAL

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.

Also known as: VR-DOT, VPH-DARE@IT
Alterniity Augmented Reality (AAR)
VideoGradeBEHAVIORAL

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

Active

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 10977568BACKGROUND

  • 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.

    PMID: 25658491BACKGROUND

  • 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.

    PMID: 23147007BACKGROUND

  • 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.

    PMID: 24656838BACKGROUND

  • 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.

    PMID: 25416111BACKGROUND

Related Links

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Officials

  • Magda Tsolaki, PhD

    GAADRD

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 26, 2015

First Posted

April 15, 2015

Study Start

February 1, 2015

Primary Completion

September 1, 2018

Study Completion

December 1, 2018

Last Updated

February 8, 2022

Record last verified: 2022-02