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

Attention Deficit Disorder With Hyperactivity Clinical Trial

— ADHD  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06369714
• Other study ID #: CHEC2023-296
• Status: Recruiting
• Phase: N/A
• Start date: February 24, 2023
• Est. completion date: February 24, 2025

Study information

• Verified date: April 2024
• Source: Changhai Hospital
• Contact: Yuanhao Cai, MBBS
• Phone: 15001969690
• Email: 15552283399[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: February 24, 2025
• Est. primary completion date: February 24, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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.

Related Conditions & MeSH terms

• Attention Deficit Disorder With Hyperactivity
• Executive Function Disorder
• Hyperkinesis

Intervention

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

Locations

Country	Name	City	State
China	Changhai Hospital, Naval Medical University	Shanghai	Shanghai
China	Changzheng Hospital, Naval Medical University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Lei Lei, MD

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)
Secondary	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.	Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)
Secondary	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.	Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)
Secondary	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.	Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)
Secondary	Digital Cancellation Test	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)