Digital therapy using neurofeedback for treating ADHD in children
Official title: Neurofeedback-Based Digital Therapeutics for the Diagnosis and Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Children.
Run by Changhai Hospital · NCT06369714 · Data updated 2026-11-12
This study is testing a new iPad game that uses neurofeedback and executive function training to see if it can help children aged 6 to 12 with ADHD improve their attention and thinking skills.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 6 Years to 12 Years |
| Sex | All |
| Enrollment | 210 (estimated) |
| Sponsor | Changhai Hospital Academic / other |
| Locations | 2 sites (Shanghai, Shanghai Municipality and 1 other locations) |
| Status | Recruiting |
| Started | February 24, 2023 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2025 |
| Registry record updated | June 10, 2025 |
| Trial ID | NCT06369714 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children aged 6 to 12 who meet the DSM-5 criteria for ADHD and have not received any ADHD interventions in the past four weeks.
✕Probably not a fit
Patients with comorbid psychiatric conditions or severe neurological disorders may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates a novel digital therapeutics program that combines neurofeedback training with executive function training for children aged 6 to 12 diagnosed with ADHD. The program is delivered through an engaging iPad game in a home-based format, aiming to improve attention deficits and executive function impairments. Participants will be randomly assigned to receive either medication, digital therapeutics, or a combination of both over 30 sessions within an 8-week period. The effectiveness of the interventions will be assessed through symptom reassessment and parent feedback questionnaires.
Why it matters
Potential benefit: If successful, this approach could provide a non-pharmacological treatment option for children with ADHD, potentially improving their attention and executive function.
How similar studies have gone: While the approach of combining digital therapeutics with neurofeedback is innovative, similar studies have shown promise in using digital interventions for ADHD management.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Changzheng Hospital, Naval Medical University
Shanghai, Shanghai Municipality, China Recruiting -
Changhai Hospital, Naval Medical University
Shanghai, Shanghai Municipality, China Recruiting
Study contacts
- Principal investigator: Lei Lei, MD — Department of Pediatric, Changhai Hospital, Naval Medical University
- Study coordinator: Yuanhao Cai, MBBS
- Email: 15552283399@163.com
- Phone: 15001969690
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.