Attention Deficit Disorder With HyperactivityADHDNCT06369714
Neurofeedback-Based Digital Therapeutics for the Diagnosis and Treatment of ADHD in Children.
A study testing Concerta and Digital therapeutics in people with Attention Deficit Disorder With Hyperactivity and Executive Function Disorder, run by Lei Lei, MD at 2 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Attention Deficit Disorder With Hyperactivity, Executive Function Disorder
- What is being tested?
- Concerta and Digital therapeutics
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 210 participants
- Where
- 2 sitesChina
- Study dates
- 24 Feb 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Changzheng Hospital, Naval Medical University
Shanghai, Shanghai Municipality, 200003
Yujiao Wang, MBBS, 15021500051, 2191916146@qq.com
- Recruiting
Changhai Hospital, Naval Medical University
Shanghai, Shanghai Municipality, 200433
Yuanhao Cai, MBBS, 15001969690, 15552283399@163.com
Yuanhao Cai, MBBS
About this study
Official title: 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.
- Being tested
- Concerta, Digital therapeutics
- Keywords
- Digital Therapeutics, Neurofeedback, Attention Deficit Disorders with Hyperactivity, Children, Executive function disorder
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ConcertaDrug
Also called Methylphenidate Hydrochloride Extended-Release Tablets
Methylphenidate Hydrochloride Extended-Release Tablets with the following specifications: 18mg dosage, oral administration, once a day for a duration of 8 weeks.
Digital therapeuticsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Medication group | Active comparator | The medication group will take Methylphenidate Hydrochloride Extended-Release Tablets with a fixed dose for eight weeks. Receives: Drug: Concerta |
| Digital therapeutics group | Experimental | The digital therapeutics group will complete 30 training sessions within 8 weeks. Receives: Device: Digital therapeutics |
| Combination group | Experimental | The combination group will take Methylphenidate Hydrochloride Extended-Release Tablets while undergoing digital therapeutics. Receives: Drug: Concerta; Device: Digital therapeutics |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)
Questionnaire-Children with Difficulties
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.
Measured: Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)
Behavior Rating Inventory of Executive Function
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.
Measured: Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)
Continuous Performance Test
A newly designed Continuous Performance Test (CPT) will be administered to participants by investigators, with higher accuracy rates indicating a better outcome.
Measured: Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)
Digital Cancellation Test
The Digit Cancellation Test (DCT) will be administered to participants by investigators, with higher scores indicating a better outcome.
Measured: Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start24 Feb 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Attention Deficit Disorder With HyperactivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 210 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lei Lei, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Lei Lei, MD, Changhai Hospital
- Investigators
- Lei Lei, MD, Principal investigator, Department of Pediatric, Changhai Hospital, Naval Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06369714
- Sponsor's protocol ID
- CHEC2023-296
- Acronym
- ADHD
- Status last verified
- Jun 2025
- First submitted
- 2 Apr 2024
- Last updated
- 10 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhao X, Cai Y, Zhang X, Xu T, Qian Y, Hao W, Wang Y, Yuan J, Cai T, Zhou L, Li H, Lei L. Cross-training digital therapeutics for pediatric ADHD: study protocol for a randomized controlled trial. Trials. 2026 May 18;27(1):484. doi: 10.1186/s13063-026-09775-4.
PubMed 42152117
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurofeedback-Based Digital Therapeutics for the Diagnosis and Treatment of Attention Deficit Hyperactivity Disorder (ADHD) in Children.
- ClinicalTrials.gov ID
- NCT06369714
- Acronym / sponsor ID
- ADHD / CHEC2023-296
- Keywords
- Digital Therapeutics, Neurofeedback, Attention Deficit Disorders with Hyperactivity, Children, Executive function disorder
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 210 participants (estimated)
- Lead sponsor
- Lei Lei, MDUniversity, hospital or other
- Study start
- 24 Feb 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Medication group | Active comparator | Drug: ConcertaThe medication group will take Methylphenidate Hydrochloride Extended-Release Tablets with a fixed dose for eight weeks. |
| Digital therapeutics group | Experimental | Device: Digital therapeuticsThe digital therapeutics group will complete 30 training sessions within 8 weeks. |
| Combination group | Experimental | Drug: Concerta, Device: Digital therapeuticsThe combination group will take Methylphenidate Hydrochloride Extended-Release Tablets while undergoing digital therapeutics. |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ConcertaAlso: Methylphenidate Hydrochloride Extended-Release TabletsMethylphenidate Hydrochloride Extended-Release Tablets with the following specifications: 18mg dosage, oral administration, once a day for a duration of 8 weeks. | Drug | Combination group, Medication group |
| Digital therapeutics30 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. | Device | Combination group, Digital therapeutics group |
Primary outcome
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.
5 secondary outcomes
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)
Questionnaire-Children with Difficulties
Time frame: 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)
Continuous Performance Test
Time frame: 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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2025.
- Derived from this study: PubMed 42152117Zhao X, Cai Y, Zhang X, Xu T, Qian Y, Hao W, Wang Y, Yuan J, Cai T, Zhou L, Li H, Lei L. Cross-training digital therapeutics for pediatric ADHD: study protocol for a randomized controlled trial. Trials. 2026 May 18;27(1):484. doi: 10.1186/s13063-026-09775-4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lei Lei, MD principal investigator
Department of Pediatric, Changhai Hospital, Naval Medical University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Concerta and Digital therapeutics in people with Attention Deficit Disorder With Hyperactivity and Executive Function Disorder, run by Lei Lei, MD at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuanhao Cai, MBBS (15001969690, 15552283399@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Swanson, Nolan, and Pelham IV Rating Scale (time frame: Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06369714, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jun 2025.