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

June 8, 2025 updated by: Lei Lei, MD

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

210

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Shanghai
      • Shanghai, Shanghai, China, 200003
        • Recruiting
        • Changzheng Hospital, Naval Medical University
        • Contact:
      • Shanghai, Shanghai, China, 200433
        • Recruiting
        • Changhai Hospital, Naval Medical University
        • Contact:
        • Sub-Investigator:
          • Yuanhao Cai, MBBS
        • Principal Investigator:
          • Lei Lei, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Medication group
The medication group will take Methylphenidate Hydrochloride Extended-Release Tablets with a fixed dose for eight weeks.
Drug: Concerta
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
Experimental: Digital therapeutics group
The digital therapeutics group will complete 30 training sessions within 8 weeks.
Device: Digital therapeutics
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.
Experimental: Combination group
The combination group will take Methylphenidate Hydrochloride Extended-Release Tablets while undergoing digital therapeutics.
Drug: Concerta
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
Device: Digital therapeutics
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)
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.
Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)
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.
Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)
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.
Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)
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.
Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lei Lei, MD

Investigators

  • Principal Investigator: Lei Lei, MD, Department of Pediatric, Changhai Hospital, Naval Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

April 2, 2024

First Submitted That Met QC Criteria

April 15, 2024

First Posted (Actual)

April 17, 2024

Study Record Updates

Last Update Posted (Actual)

June 10, 2025

Last Update Submitted That Met QC Criteria

June 8, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHEC2023-296

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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