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

Lei Lei, MD

Status: Enrolling

Conditions: Attention Deficit Disorder with Hyperactivity; Executive Function Disorder

Treatments: Drug: Concerta; Device: Digital therapeutics

Study type: Interventional

Funder types: Other

Identifiers

NCT06369714

CHEC2023-296

Details and patient eligibility

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 3 patient groups

Medication group

Active Comparator group

Description:

The medication group will take Methylphenidate Hydrochloride Extended-Release Tablets with a fixed dose for eight weeks.

Treatment:

Drug: Concerta

Digital therapeutics group

Experimental group

Description:

The digital therapeutics group will complete 30 training sessions within 8 weeks.

Treatment:

Device: Digital therapeutics

Combination group

Experimental group

Description:

The combination group will take Methylphenidate Hydrochloride Extended-Release Tablets while undergoing digital therapeutics.

Treatment:

Device: Digital therapeutics

Drug: Concerta