Assessment of ARVO Web-based Software for Evaluating Attention-Deficit/Hyperactive Disorder (ADHD) Symptoms in Children

Assessment of ARVO Web-based Software for Evaluating Attention-Deficit/Hyperactive Disorder (ADHD) Symptoms in Children. Prospective, Controlled Clinical Investigation

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 Overview

• Status: Completed
• Conditions: Attention Deficit Disorder With Hyperactivity
• Intervention / Treatment: Device: ARVO 2.0 WEB; Other: Conners Continuous Performance Test 3rd Edition™ (CPT 3)

• Study Type: Interventional
• Enrollment (Actual): 134
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Espoo, Finland, 02650
    • Pro Neuron Oy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

ADHD group

The Inclusion criteria:

1. Signed informed consent (by guardian and a child)
2. Age of 8-13 at the time of consent
3. ADHD set by a licensed physician
4. Native language Finnish / Fluent Finnish language

TD group

The Inclusion criteria:

1. Signed informed consent (by guardian and child)
2. Age of 8-13 at the time of the consent
3. Native language Finnish / Fluent Finnish language

Exclusion Criteria:

ADHD group

1. Any diseases of the nervous system (ICD-10, G00-G99)
2. Mental and behavioural disorders due to psychoactive substance use (F10-F19)
3. Schizophrenia, schizotypal and delusional disorders (F20 - F29)
4. Acute severe depression or mania / hypomania (F30, F32, F33)
5. Phobic anxiety disorders, other anxiety disorders, obsessive-compulsive disorder (F40-F42)
6. Severe mental retardation (F72)
7. Disorders of psychological development (F80, F81, F83, F84)
8. Medication taken for ADHD (methylphenidate, lisdexamfetamine) on the test day (24 hour wash out)
9. Atomoxetine, guanfacine
10. Hearing or vision diagnosis (H90 Bilateral hearing loss, H53 Visual disturbances, H54 Blindness and low vision) Diagnosis search completeness criteria: Diagnosis present/absent in patient registry Kanta.

TD group

1. Set ADHD diagnosis.
2. Ongoing process related to setting an ADHD diagnosis, according to guardian's questionnaire.
3. Any diseases of the nervous system (ICD-10, G00-G99)
4. Mental and behavioural disorders due to psychoactive substance use (F10-F19)
5. Schizophrenia, schizotypal and delusional disorders (F20 - F29)
6. Acute severe depression or mania / hypomania (F30, F32, F33)
7. Phobic anxiety disorders, other anxiety disorders, obsessive-compulsive disorder (F40-F42)
8. Severe mental retardation (F72)
9. Disorders of psychological development (F80, F81, F83, F84)
10. Hearing or vision diagnosis (H90 Bilateral hearing loss, H53 Visual disturbances, H54 Blindness and low vision)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TD; Children of 8-13 years of age without any neuropsychiatric diagnose (typically developed)	Device: ARVO 2.0 WEB; 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.; Other: Conners Continuous Performance Test 3rd Edition™ (CPT 3); 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
Experimental: ADHD; Children of 8-13 years of age with previously diagnosed ADHD symptoms	Device: ARVO 2.0 WEB; 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.; Other: Conners Continuous Performance Test 3rd Edition™ (CPT 3); 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ARVO and CPT 3 neuropsychiatric indicators (NPIs)	To confirm that ARVO is equivalent to (CPT 3) regarding predictive validity (AUC)	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.	At Visit 1 (four weeks after V0 enrollment) immediately upon completed ARVO test

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)	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	Visit 1 test event (four weeks after V0 enrollment)

Collaborators and Investigators

• Sponsor: Peili Vision Ltd.
• Investigators: Principal Investigator: Sami Leppämäki, MD, PhD, Pro Neuron Oy

Study record dates

Study Major Dates

• Study Start (Actual): November 6, 2023
• Primary Completion (Actual): August 14, 2024
• Study Completion (Actual): August 14, 2024

Study Registration Dates

• First Submitted: April 19, 2023
• First Submitted That Met QC Criteria: May 4, 2023
• First Posted (Actual): May 6, 2023

Study Record Updates

• Last Update Posted (Actual): September 4, 2024
• Last Update Submitted That Met QC Criteria: September 2, 2024
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Keywords: ADHD
• Additional Relevant MeSH Terms: Mental Disorders; Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Attention Deficit Disorder with Hyperactivity
• Other Study ID Numbers: Arvo-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: By utilizing the data collected in this clinical investigation, the suitability of the web browser version of ARVO test to identify ADHD will be evaluated by metrics including number of correctly performed tasks, task efficiency, navigation efficiency, number of functions, and mouse movement speed. Additionally, it will be evaluated whether other metrics that are central to the assessment of ADHD can be identified from the collected data.
• IPD Sharing Time Frame: 2024-2030
• IPD Sharing Access Criteria: Scientific research as defined in the Clinical Investigation Plan and supporting documents.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No