Neurofeedback-Based Digital Therapeutics for the Diagnosis and Treatment of ADHD in Children.

Launched by LEI LEI, MD · Apr 15, 2024

Keywords

ClinConnect Summary

This clinical trial is exploring a new treatment for children aged 6 to 12 who have Attention Deficit Hyperactivity Disorder (ADHD). The study aims to see how effective a fun and interactive iPad game, which combines brain training (called neurofeedback) and skills training for thinking and organizing (known as executive function training), can be in improving attention and focus in kids with ADHD. Participants will be divided into three groups: one group will receive medication alone, another will use the digital game alone, and the third group will get both treatments together. Over eight weeks, each child will participate in 30 sessions, each lasting about 30 minutes. At the end of the trial, researchers will check how well the treatments worked by assessing the children's symptoms and gathering feedback from their parents.

To be eligible for this trial, children must meet specific criteria, such as having a diagnosis of ADHD according to established guidelines, being between 6 and 12 years old, and not having received any ADHD treatments in the past four weeks. It’s important to note that children with certain other mental health conditions or serious neurological issues cannot participate. This trial is currently recruiting participants and hopes to find out if this digital approach can help make a difference in managing ADHD symptoms alongside traditional medications.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Meet the diagnostic criteria established by the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders (DSM-5) for ADHD.
• • Digital Cancellation Test total score\<50 points.
• • Raven's Standard Progressive Matrices score≥85.
• • 6 years ≤ Age\<12 years.
• • No interventions for ADHD received within 4 weeks.
• • No color blindness.
• Exclusion Criteria:
• • Patients with organic mental disorders, schizophrenia, bipolar disorder, depressive disorders, and other psychiatric conditions.
• • Patients with comorbid autism spectrum disorder, Tourette's syndrome, and other neurodevelopmental disorders.
• • Patients with comorbid conduct disorders.
• • Patients with severe traumatic brain injury or neurological disorders.
• • Patients with a history of severe somatic diseases.
• • Patients with a history of substance or drug dependency.