Neurofeedback-Based Digital Therapeutics for the Diagnosis and Treatment of ADHD in Children.
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorLei Lei, MD
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Concerta
DrugMethylphenidate Hydrochloride Extended-Release Tablets with the following specifications: 18mg dosage, oral administration, once a day for a duration of 8 weeks.
Digital therapeutics
Device30 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.
Treatment groups
210 Participants
are divided into 3 treatment groupsGroup A: Medication groupActive comparator 1 intervention
Group B: Digital therapeutics groupExperimental treatment 1 intervention
Group C: Combination groupExperimental treatment 2 interventions
Trial outcomes
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.
Time frame
Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)Secondary outcomes
1
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.
Time frame
Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)2
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.
Time frame
Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)3
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.
Time frame
Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)4
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.
Time frame
Baseline to End of Treatment (Week 8) and to Follow-up (Week 20, Week 32)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Lei Lei, MD
Lead sponsor
Changhai Hospital
Sponsor institution
Source ClinicalTrials.gov