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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Weiping Xia
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Study coordinator: Weiping Xia, PhD
• Email: summertree20@163.com
• Phone: +8613761137709

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.