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

NCT ID: NCT05846815

Last Updated: 2024-09-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 134 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-06
• Study Completion Date: 2024-08-14

Brief Summary

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.

Conditions

Attention Deficit Disorder With Hyperactivity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TD

Children of 8-13 years of age without any neuropsychiatric diagnose (typically developed)

Group Type: EXPERIMENTAL

ARVO 2.0 WEB

Intervention Type: DEVICE

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.

Conners Continuous Performance Test 3rd Edition™ (CPT 3)

Intervention Type: OTHER

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

ADHD

Children of 8-13 years of age with previously diagnosed ADHD symptoms

Group Type: EXPERIMENTAL

ARVO 2.0 WEB

Intervention Type: DEVICE

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.

Conners Continuous Performance Test 3rd Edition™ (CPT 3)

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DEVICE

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

ADHD group

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

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)

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Peili Vision Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sami Leppämäki, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Pro Neuron Oy

Locations

Pro Neuron Oy

Espoo, , Finland

Countries

Finland

Other Identifiers

Arvo-001

Identifier Type: -

Identifier Source: org_study_id