Clinical investigation is aimed to assess the performance and safety of web-based ARVO 2.0, for evaluating possible Attention-Deficit/Hyperactive Disorder (ADHD) symptoms in children. Possible ADHD symptoms are recorded by using specific predetermined neurocognitive performance indicators (NPI's), derived during/from the game. Results of ARVO are compared to the Conners Continuous Performance Test 3rd Edition™ (CPT 3) that is a task-oriented, automated 14-minute computerized assessment of attention-deficit (AD) related problems in individuals aged 8 years and older. Performance and safety of ARVO and CPT 3 are compared in two clinical investigation populations, 8-13 years old ADHD children and typically developing (TD) children of the same age. Test are performed by the subject while monitoring adult supervises safety of the use.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
134
Medical device software where the subject navigates in a virtual apartment, with the goal of performing the tasks given by a cartoon dragon character. The child is asked to perform the subtasks in the given order, except for the subtasks to be completed at a certain time or after a certain sound cue, but the completion order does not influence the scoring. One task scenario lasts until all subtasks are correctly performed or until the time limit of 60 s is reached. The classification whether the subject belong to typically developed population is based on quantitative neurological performance indicators produced during the game. However, even if the activity performed is differential diagnostics, ARVO does not create any medical diagnosis. It shall be also noted that in the present clinical investigation, the interpretation of the results regarding child's ADHD susceptibility is not performed.
Subjects are required to respond by pressing the spacebar or the appropriate key on the mouse when any letter other than the letter "X" appears on the monitor. The Conners CPT 3 presents 14-minute, 360 scored stimuli trials (i.e., individual letters) on the screen, with 1, 2, or 4 sec. between the presentation of letters (i.e., the interstimulus interval; ISI). The 360 trials are divided into 6 blocks, with 3 sub-blocks each consisting of 20 trials. Each block lasts approximately 2 min and 20 sec. Scores and Score Dimensions of Attention Measured: Inattentiveness, Impulsivity, Sustained Attention and Vigilance. The Conners CPT 3 produces computer-generated reports that describe the respondent's performance. It shall be also noted that in the present clinical investigation, the interpretation of the results regarding child's ADHD susceptibility is not performed
Pro Neuron Oy
Espoo, Finland
ARVO and CPT 3 neuropsychiatric indicators (NPIs)
To confirm that ARVO is equivalent to (CPT 3) regarding predictive validity (AUC)
Time frame: At Visit 1 test event (four weeks after V0 enrollment)
Children SSQ score
To confirm that ARVO is safe as defined by Simulator Sickness Score (SSQ) value 0, 1, or 2.
Time frame: At Visit 1 (four weeks after V0 enrollment) immediately upon completed ARVO test
ARVO and CPT 3 neuropsychiatric indicators (NPIs)
To confirm that ARVO is equivalent to CPT 3 regarding individual NPIs ability to differentiate ADHD and TD groups
Time frame: Visit 1 test event (four weeks after V0 enrollment)
ARVO NPIs mean score and ADHR-RS for parent score
To confirm that ARVO is equivalent to ADHD-RS regarding concurrent validity (correlation)
Time frame: Visit 1 test event (four weeks after V0 enrollment)
Smileyometer and Fun Sorter
To confirm that ARVO is superior to CPT 3 regarding use experience
Time frame: Visit 1 test event (four weeks after V0 enrollment)
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