Effectiveness of a Mobile Neurofeedback for ADHD Youth
- Conditions
- Attention Deficit Hyperactivity Disorder
- Interventions
- Device: Sham mobile neurofeedbackDevice: medication + Sham mobile neurofeedbackDevice: mobile neurofeedbackDevice: medication + mobile neurofeedback
- Registration Number
- NCT04469335
- Lead Sponsor
- Seoul National University Childrens Hospital
- Brief Summary
Objective: Verification of ADHD Treatment Effectiveness of Mobile Neurofeedback to Subjects of Child and Youth with ADHD.
Method: Mobile Neurofeedback Program is implemented for 165 ADHD patients aged 8 to 15 to verify their effectiveness by conducting pre-post evaluation. Prior to the implementation of the intervention, we conduct a survey with demographic information, behavioral characteristics, clinical global impression, neuropsychological test, brain MRI, NIRS and EEG.
The drug naive subjects are randomly assigned to the mobile Neurofeedback group or Sham control group. The subjects on medication are randomly assigned to the mobile Neurofeedback group or Sham control group, In addition to the medication being administered.
The intervention are conducted three times a week, twice a day, and 10-20 minutes for 12 weeks, and the effectiveness is assessed four times in advance, third month, sixth month and twelfth months.
However, the Sham control group were provided the same machines and programs as the Neurofeedback exercise, but feedback is generated randomly regardless of ectroencephalogram change of the subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 165
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patient between the ages of 8 and 15
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Patients diagnosed with ADHD in accordance with DSM-5 diagnostic criteria and K-SADS-PL ③ IQ 80 or higher ④ Neurofeedback or Sham treatment group include patients who have not received methylphenidate/atomoxetine medication in the past or who have been treated with methylphenidate less than a year and not taken methylphenidate/atomoxetine within four weeks of starting point of this study.
- medication+Neurofeedback or medication+Sham treatment group include ADHD patients undergoing methylphenidate or atomoxetine medication over the past month without changes in capacity. And ADHD patients whose CGI-S scale is 4 or higher.
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Patients diagnosed with congenital genetic disease
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Patients with a clear history of acquired brain damage, such as cerebral palsy. ③ Patients with convulsions, other neurological disorders, or uncorrected sensory disorders
- Patients with a history of schizophrenia, other childhood psychosis ⑤ IQ below 80 ⑥ Patient with obsessive compulsive disorder, major depression or bipolar disorder
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description sham control Sham mobile neurofeedback - medication + sham control medication + Sham mobile neurofeedback - mobile neurofeedback mobile neurofeedback - medication +mobile neurofeedback medication + mobile neurofeedback -
- Primary Outcome Measures
Name Time Method Korean Attention Deficit Hyperactivity Disorder rating scale twelfth month Clinical Global Impression Scale-Severity twelfth month Children's Global Assessment Scale twelfth month
- Secondary Outcome Measures
Name Time Method brain MRI at the beginning, third month, sixth month, twelfth month EEG power in beta band at the beginning, third month, sixth month, twelfth month EEG power in theta band at the beginning, third month, sixth month, twelfth month Near Infra-Red Spectroscopy at the beginning, third month, sixth month, twelfth month
Trial Locations
- Locations (1)
Seoul National University Childrens' Hospital
🇰🇷Seoul, Korea, Republic of