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NCT Number: NCT06369714

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

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.

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Key information

Conditions

Attention Deficit Disorder With Hyperactivity Attention Deficit and Disruptive Behavior Disorders Executive Function Disorder Mental Disorders Neurodevelopmental Disorders

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Changhai Hospital, Naval Medical University, Shanghai, Shanghai Municipality, China

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Concerta

Drug

Methylphenidate Hydrochloride Extended-Release Tablets with the following specifications: 18mg dosage, oral administration, once a day for a duration of 8 weeks.

Other names: Methylphenidate Hydrochloride Extended-Release Tablets

Digital Therapeutics

Device

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 outcomes

  1. Swanson, Nolan, and Pelham IV Rating Scale

    Time frame: Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)

    The Swanson, Nolan, and Pelham IV Rating Scales (SNAP-IV) will be completed by parents to assess the severity of ADHD symptoms. The values range from 0 to 3, with lower scores indicating a better outcome.

Secondary outcomes

  1. 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)

    The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for ADHD will be used to assess the number of core symptoms. There are a total of 18 core symptoms, with fewer symptoms indicating a better outcome.

  2. Questionnaire-Children with Difficulties

    Time frame: Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)

    The Questionnaire-Children with Difficulties (QCD) will be completed by parents to assess the social abilities of participants. The total questionnaire score is 57, and a score below 30 suggests impaired functioning.

  3. Behavior Rating Inventory of Executive Function

    Time frame: Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)

    The Behavior Rating Inventory of Executive Function (BRIEF) will be completed by parents to assess changes in executive function. The normal standards for scores vary by age, with lower scores indicating a better outcome.

  4. Continuous Performance Test

    Time frame: Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)

    A newly designed Continuous Performance Test (CPT) will be administered to participants by investigators, with higher accuracy rates indicating a better outcome.

  5. Digital Cancellation Test

    Time frame: Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)

    The Digit Cancellation Test (DCT) will be administered to participants by investigators, with higher scores indicating a better outcome.

Study contacts

Contact information is provided by the study sponsor or research team.

Lei Lei, MD

CONTACT

[email protected]

13916072205

Yuanhao Cai, MBBS

CONTACT

[email protected]

15001969690

Sponsors and collaborators

Lead sponsor

Lei Lei, MD

Other

Registry information

Official study title

Neurofeedback-Based Digital Therapeutics for the Diagnosis and Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Children.

Acronym: ADHD

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Apr 17, 2024
Registry last updated
Jun 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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