Actively Recruiting
Neurofeedback-Based Digital Therapeutics for the Diagnosis and Treatment of ADHD in Children.
Led by Lei Lei, MD · Updated on 2025-06-10
210
Participants Needed
2
Research Sites
148 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Neurofeedback-Based Digital Therapeutics for the Diagnosis and Treatment of ADHD in Children.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 less than 50 points.
- Raven's Standard Progressive Matrices score of 85 or higher.
- Age between 6 and 12 years.
- No ADHD interventions received within 4 weeks prior to enrollment.
- No color blindness.
You will not qualify if you...
- Diagnosis of organic mental disorders, schizophrenia, bipolar disorder, depressive disorders, or other psychiatric conditions.
- Comorbid autism spectrum disorder, Tourette's syndrome, or other neurodevelopmental disorders.
- Presence of conduct disorders.
- History of severe traumatic brain injury or neurological disorders.
- History of severe somatic diseases.
- History of substance or drug dependency.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Changzheng Hospital, Naval Medical University
Shanghai, Shanghai Municipality, China, 200003
Actively Recruiting
2
Changhai Hospital, Naval Medical University
Shanghai, Shanghai Municipality, China, 200433
Actively Recruiting
Research Team
Y
Yuanhao Cai, MBBS
CONTACT
L
Lei Lei, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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