Effectiveness of a Mobile Neurofeedback for ADHD Youth

  • STATUS
    Recruiting
  • participants needed
    165
  • sponsor
    Seoul National University Childrens Hospital
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Updated on 19 February 2024
See if I qualify
sham treatment
atomoxetine
methylphenidate
attention deficit hyperactivity disorder
neuropsychological test
neurofeedback
magnetic resonance imaging of brain

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.

Details
Condition Oppositional Defiant Disorder, Attention deficit hyperactivity disorder
Age 8years - 15years
Treatment mobile neurofeedback, Sham mobile neurofeedback, medication + mobile neurofeedback, medication + Sham mobile neurofeedback
Clinical Study IdentifierNCT04469335
SponsorSeoul National University Childrens Hospital
Last Modified on19 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

patient between the ages of 8 and 15
Patients diagnosed with ADHD in accordance with DSM-5 diagnostic criteria and K-SADS-PL IQ 80 or higher 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

Exclusion Criteria

Patients diagnosed with congenital genetic disease
Patients with a clear history of acquired brain damage, such as cerebral palsy. Patients with convulsions, other neurological disorders, or uncorrected sensory disorders
Patients with a history of schizophrenia, other childhood psychosis IQ below 80 Patient with obsessive compulsive disorder, major depression or bipolar disorder
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magnetic resonance imaging of brain

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