Attention-Deficit/Hyperactivity Disorder
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1.Aged 3–18 years, with no gender restriction; 2.Meet the diagnostic criteria for ADHD (attention-deficit subtype or combined subtype) according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V); 3.Full-scale IQ >= 70 as assessed by the Wechsler Intelligence Scale for Children (Chinese Revised Edition, Second Version); 4.Not using methylphenidate, atomoxetine, traditional Chinese medicines (e.g., Duodongning Capsules, Xiao’er Zhili Syrup, Jingling Oral Liquid, or other Chinese herbal formulas) or other ADHD medications, or have discontinued such medications for at least 2 weeks prior to screening; 5.The guardian agrees to participate and cooperate with the study, and voluntarily signs the informed consent form;
Exclusion criteria
Exclusion criteria: 1.History of tic disorder; 2.History of previous seizure episodes; 3.Patients with a history of childhood schizophrenia, affective disorders, autism, or mental retardation; 4.Cranial imaging findings suggest significant organic lesions; 5.Electrocardiogram (ECG) findings suggest arrhythmia; 6.Routine blood tests and liver and kidney function tests suggest the presence of a serious physical illness; 7.Participation in other clinical drug observation studies; 8.Presence of metal implants in the body.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical symptoms assessed using the SNAP-IV questionnaire.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Weiss Functional Impairment Rating Scale (WFIRS);Phase Lag Index (PLI);The Conners' Parent Rating Scale (CPRS);Safety evaluation: general vital signs, neurological adverse events, hearing impairment, local scalp reactions, cognitive and emotional adverse events, and serious adverse events (SAEs).; | — |
Countries
China
Contacts
Shanghai Yangzhi Rehabilitation Hospital (Shanghai Sunshine Rehabilitation Center)