Impact of NeuroWorld Digital Therapy on Attention Function and Symptoms in Children Diagnosed with ADHD

A prospective, single-center, standard-of-care parallel-controlled, randomized, superiority, exploratory clinical trial to evaluate the efficacy and safety of Neuro-World DTx digital therapy on attention function and symptoms in children diagnosed with ADHD

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0009862

Enrollment

Registered

2024-10-18

Start date

2024-10-07

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : Experimental Group: Maintains the use of previously prescribed medication while incorporating the digital therapeutic intervention. Control Group: Continues to use the previously pres

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Individuals who have provided voluntary written consent from their legal guardian and have also agreed to participate themselves. 2. Children aged 6 to 12 years who have been diagnosed with ADHD according to the criteria outlined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) at the time of screening. 3. Individuals currently receiving medication treatment for ADHD. 4. Individuals who have a score of 80 or above on the Korean version of the Wechsler Intelligence Scale for Children. 5. Individuals who are able to comply with the evaluation and instructions of the principal investigator.

Exclusion criteria

Exclusion criteria: 1. Individuals with disorders or conditions other than ADHD (such as post-traumatic stress disorder, psychosis, severe obsessive-compulsive disorder, major depression, or conduct disorder). 2. Individuals with conditions that may affect the use of the clinical trial product (such as physical deformities of the hands or arms, or prosthetics). 3. Individuals with a confirmed or suspected history of substance abuse or dependence within 6 months prior to screening. 4. Individuals who have participated in another ADHD-related clinical trial within 90 days prior to screening. 5. Individuals exhibiting color blindness. 6. Individuals with a score of 79 or below on the Korean version of the Wechsler Intelligence Scale for Children, indicating intellectual disability. 7. Individuals whose family members are currently enrolled in or participating in the same clinical trial. 8. Individuals deemed by the investigator to be unsuitable for participation in the clinical trial for any other reason.

Design outcomes

Primary

Measure	Time frame
K-WISC-V Processing Speed Change Rate	—

Secondary

Measure	Time frame
Change in Comprehensive Attention Test (CAT);Change in Korean ADHD Rating Scale (K-ARS);Change in Clinical Global Impression Scale (CGI);Change in Korean Child Behavior Checklist (K-CBCL);Change in Frankfurter Aufmerksamkets InventaR (FAIR);Frustration, Headache, Dizziness for Safety Assessment	—

Countries

Korea, Republic of

Contacts

Public ContactNAYEONG KONG

Keimyung University Dongsan Hospital

kp8937@gmail.com+82-53-258-4882

Outcome results