Neurofeedback-Based Digital Therapeutics for the Diagnosis and Treatment of ADHD in Children.
ADHD
1 other identifier
interventional
210
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2023
Typical duration for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 24, 2023
CompletedFirst Submitted
Initial submission to the registry
April 2, 2024
CompletedFirst Posted
Study publicly available on registry
April 17, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedJune 10, 2025
June 1, 2025
2.9 years
April 2, 2024
June 8, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Swanson, Nolan, and Pelham IV Rating Scale
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 Outcomes (5)
Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition criteria for ADHD
Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)
Questionnaire-Children with Difficulties
Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)
Behavior Rating Inventory of Executive Function
Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)
Continuous Performance Test
Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)
Digital Cancellation Test
Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)
Study Arms (3)
Medication group
ACTIVE COMPARATORThe medication group will take Methylphenidate Hydrochloride Extended-Release Tablets with a fixed dose for eight weeks.
Digital therapeutics group
EXPERIMENTALThe digital therapeutics group will complete 30 training sessions within 8 weeks.
Combination group
EXPERIMENTALThe combination group will take Methylphenidate Hydrochloride Extended-Release Tablets while undergoing digital therapeutics.
Interventions
Methylphenidate Hydrochloride Extended-Release Tablets with the following specifications: 18mg dosage, oral administration, once a day for a duration of 8 weeks.
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.
Eligibility Criteria
You may qualify if:
- 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.
- years ≤ Age\<12 years.
- No interventions for ADHD received within 4 weeks.
- No color blindness.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Lei Lei, MDlead
Study Sites (2)
Changzheng Hospital, Naval Medical University
Shanghai, Shanghai Municipality, 200003, China
Changhai Hospital, Naval Medical University
Shanghai, Shanghai Municipality, 200433, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lei Lei, MD
Department of Pediatric, Changhai Hospital, Naval Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Associate Chief Physician, Principal Investigator
Study Record Dates
First Submitted
April 2, 2024
First Posted
April 17, 2024
Study Start
February 24, 2023
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
June 10, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share