Neurofeedback-Based Digital Therapeutics for the Diagnosis and Treatment of ADHD in Children.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Concerta, Digital therapeutics.
- Who it may be relevant to
- Registry conditions: Attention Deficit Disorder With Hyperactivity, Executive Function Disorder. Basic parameters: 6 years — 12 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Neurofeedback-Based Digital Therapeutics for the Diagnosis and Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Children.
Overview
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.
Interventions
- 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.
Primary outcome measures
- Swanson, Nolan, and Pelham IV Rating Scale [Time frame: Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)]
Secondary outcome measures (5)
- Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for ADHD [Time frame: Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)]
- Questionnaire-Children with Difficulties [Time frame: Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)]
- Behavior Rating Inventory of Executive Function [Time frame: Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)]
- Continuous Performance Test [Time frame: Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)]
- Digital Cancellation Test [Time frame: Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Changzheng Hospital, Naval Medical University — Shanghai
- Changhai Hospital, Naval Medical University — Shanghai
Publications
- Zhao X, Cai Y, Zhang X, Xu T, Qian Y, Hao W, Wang Y, Yuan J, Cai T, Zhou L, Li H, Lei L. Cross-training digital therapeutics for pediatric ADHD: study protocol for a randomized controlled trial. Trials. 2026 May 18;27(1):484. doi: 10.1186/s13063-026-09775-4. PMID 42152117
Identifiers
NCT: NCT06369714 · CHEC2023-296