Home-based brain-controlled game therapy for children with ADHD

Randomized Controlled Study on Home-Based Digital Therapy Intervention for School-Aged Children With Attention Deficit Hyperactivity Disorder Based on Brain-Controlled Games

This study will test whether home-based brain-controlled game therapy can help reduce core ADHD symptoms in children aged 7 to 11 with mild to moderate ADHD.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 146 (estimated)
• Ages: 7 Years to 11 Years
• Sex: All
• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine (other)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07552909 on ClinicalTrials.gov

What this trial studies

Children aged 7 to 11 with physician-diagnosed mild to moderate ADHD and full-scale IQ above 85 are randomized to receive home-based digital neurofeedback (brain-controlled) game therapy or a control condition. Caregivers supervise at-home game sessions while baseline and follow-up clinical and cognitive assessments are conducted at Xinhua Hospital, Shanghai Jiao Tong University School of Medicine. The trial enrolls newly diagnosed or untreated outpatients and excludes those with sensory impairments, inability to use the software, or comorbid neurodevelopmental or major psychiatric disorders. Primary outcomes focus on changes in core ADHD symptoms using standardized rating scales and objective cognitive measures.

Who should consider this trial

Good fit: Ideal candidates are outpatient children aged 7 to 11 with a physician-confirmed diagnosis of mild to moderate ADHD, full-scale IQ above 85, and no ADHD treatment within the prior month or four weeks off medication.

Not a fit: Children with severe ADHD, comorbid neurodevelopmental or major psychiatric disorders, sensory impairments, or inability to use the game software are unlikely to benefit from this intervention.

Why it matters

Potential benefit: If successful, this could offer a non-drug, home-delivered therapy to reduce inattention and hyperactivity in children with ADHD.

How similar studies have performed: Previous neurofeedback studies for ADHD have produced mixed results, and fully home-based brain-controlled game interventions are relatively novel with limited but promising pilot data.

Eligibility criteria

Inclusion Criteria:

* Children aged 7 years 0 months to 11 years 11 months
* Clinical diagnosis of ADHD made by a child psychiatrist at the attending level or above
* Wechsler Intelligence Scale for Children (WISC) Full Scale IQ (FSIQ) above 85
* Children who have been diagnosed with ADHD but have not received any intervention (newly diagnosed within the last month or not having taken medication for at least 4 weeks)
* Informed consent must be obtained from the patient/guardian and from participants

Exclusion Criteria:

* Auditory or visual illness or disorder
* Inability to use software (e.g., color blindness, impaired hand function, or disability)
* Comorbid oppositional defiant disorder, autism spectrum disorder, pervasive developmental disorder, tic disorders, or other neurodevelopmental disorders
* Other mental illnesses such as organic mental disorders, schizophrenia, bipolar disorder, or depressive disorders
* Attention deficit disorder caused by organic neurological diseases or other organic diseases
* Previous regular ADHD medication use as prescribed by a doctor, but without efficacy
* Past or present gaming addiction
* Previous neurofeedback-like "brain control game" interventions
* Previous physical therapy such as magnetic stimulation.

Where this trial is running

Shanghai, Shanghai Municipality

• Weiping Xia — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Weiping Xia, PhD

Conditions: Attention Deficit Hyperactivity Disorder, Attention deficit hyperactivity disorder, Randomized Controlled, Digital Brain-controlled