RECRUITINGINTERVENTIONAL

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

Neurofeedback-Based Digital Therapeutics for the Diagnosis and Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Children.

About This Trial

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 treatment. Additionally, questionnaires will be distributed to parents to gather their insights and feedback on the treatment approach. This innovative digital therapeutics approach is expected to improve ADHD symptoms individually and enhance therapeutic outcomes when used alongside conventional drug treatment regimens.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DRUG

Concerta

Methylphenidate Hydrochloride Extended-Release Tablets with the following specifications: 18mg dosage, oral administration, once a day for a duration of 8 weeks.

DEVICE

Digital therapeutics

30 sessions of digital therapeutics, each lasting 30 minutes, will be conducted with a frequency of once every 1-2 days over an 8-week period.

Locations (2)

Changzheng Hospital, Naval Medical University

Shanghai, Shanghai Municipality, China

Changhai Hospital, Naval Medical University

Shanghai, Shanghai Municipality, China