Clinical trial NCT06369714: Neurofeedback-Based Digital Therapeutics for the Diagnosis and Treatment of ADHD in Children.
Official title: Neurofeedback-Based Digital Therapeutics for the Diagnosis and Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Children.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Attention Deficit Disorder With Hyperactivity
Executive Function Disorder
Keywords: Digital Therapeutics
Neurofeedback
Attention Deficit Disorders with Hyperactivity
Children
Executive function disorder
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2024-04-17
Enrollment: 210
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


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.

Primary outcomes:
measure: Swanson, Nolan, and Pelham IV Rating Scale
timeFrame: Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)
Secondary outcomes:
measure: Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for ADHD
timeFrame: Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)
measure: Questionnaire-Children with Difficulties
timeFrame: Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)
measure: Behavior Rating Inventory of Executive Function
timeFrame: Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)
measure: Continuous Performance Test
timeFrame: Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)
measure: Digital Cancellation Test
timeFrame: Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changzheng Hospital, Naval Medical University
state: Shanghai
city: Shanghai
country: China
facility: Changhai Hospital, Naval Medical University
state: Shanghai
Study officials:
affiliation: Department of Pediatric, Changhai Hospital, Naval Medical University
name: Lei Lei, MD
role: PRINCIPAL_INVESTIGATOR
References: