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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug, Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 12
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Changhai Hospital, Naval Medical University
RECRUITING
Shanghai
Changzheng Hospital, Naval Medical University
RECRUITING
Shanghai
Contact Information
Primary
Yuanhao Cai, MBBS
15552283399@163.com
15001969690
Backup
Lei Lei, MD
doctorlei_lei@163.com
13916072205
Time Frame
Start Date: 2023-02-24
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 210
Treatments
Active_comparator: Medication group
The medication group will take Methylphenidate Hydrochloride Extended-Release Tablets with a fixed dose for eight weeks.
Experimental: Digital therapeutics group
The digital therapeutics group will complete 30 training sessions within 8 weeks.
Experimental: Combination group
The combination group will take Methylphenidate Hydrochloride Extended-Release Tablets while undergoing digital therapeutics.
Sponsors
Leads: Lei Lei, MD

This content was sourced from clinicaltrials.gov