Neurofeedback-Based Digital Therapeutics for the Diagnosis and Treatment of ADHD in Children.
NCT ID: NCT06369714
Last Updated: 2025-06-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
210 participants
INTERVENTIONAL
2023-02-24
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Medication group
The medication group will take Methylphenidate Hydrochloride Extended-Release Tablets with a fixed dose for eight weeks.
Concerta
Methylphenidate Hydrochloride Extended-Release Tablets with the following specifications: 18mg dosage, oral administration, once a day for a duration of 8 weeks.
Digital therapeutics group
The digital therapeutics group will complete 30 training sessions within 8 weeks.
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.
Combination group
The combination group will take Methylphenidate Hydrochloride Extended-Release Tablets while undergoing digital therapeutics.
Concerta
Methylphenidate Hydrochloride Extended-Release Tablets with the following specifications: 18mg dosage, oral administration, once a day for a duration of 8 weeks.
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.
Interventions
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Concerta
Methylphenidate Hydrochloride Extended-Release Tablets with the following specifications: 18mg dosage, oral administration, once a day for a duration of 8 weeks.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
6 Years
12 Years
ALL
No
Sponsors
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Lei Lei, MD
OTHER
Responsible Party
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Lei Lei, MD
Associate Chief Physician, Principal Investigator
Principal Investigators
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Lei Lei, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Pediatric, Changhai Hospital, Naval Medical University
Locations
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Changzheng Hospital, Naval Medical University
Shanghai, Shanghai Municipality, China
Changhai Hospital, Naval Medical University
Shanghai, Shanghai Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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CHEC2023-296
Identifier Type: -
Identifier Source: org_study_id
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