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

RecruitingNAAges 6 Years - 12 YearsAllLei Lei, MD
NCT06369714 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

A multi-center, randomized controlled trial is being conducted to investigate the efficacy of a novel digital therapeutics (DTx) program that utilizes a cross-training approach between neurofeedback training and executive function training for pediatric patients (aged 6-12) diagnosed with ADHD. This gamified interactive program is designed to improve attention deficits and executive function impairments in pediatric patients with ADHD. It is delivered through an engaging iPad game in a home-based treatment format. Patients will be randomly assigned to one of three groups: medication alone, digital therapeutics alone, or a combination of both interventions. Subjects will undergo 30 treatment sessions over the 8-week period, with each session lasting 30 minutes. Investigators will reassess symptoms of ADHD, executive functions, and objective measures of attention at the end of the treatmen

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📋 Eligibility rules (as published)
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.
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What it tests

  • Concerta
  • Digital therapeutics
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Where

2 sites
Changzheng Hospital, Naval Medical University
Shanghai, China
Changhai Hospital, Naval Medical University
Shanghai, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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