Effectiveness of a Mobile Neurofeedback for ADHD Youth

Last updated: July 8, 2020
Sponsor: Seoul National University Childrens Hospital
Overall Status: Active - Recruiting

Phase

N/A

Condition

Attention Deficit/hyperactivity Disorder (Adhd - Adults)

Williams Syndrome

Autism Spectrum Disorder (Asd)

Treatment

N/A

Clinical Study ID

NCT04469335
1905-145-1035
  • Ages 8-15
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • patient between the ages of 8 and 15

  • Patients diagnosed with ADHD in accordance with DSM-5 diagnostic criteria andK-SADS-PL ③ IQ 80 or higher ④ Neurofeedback or Sham treatment group includepatients who have not received methylphenidate/atomoxetine medication in the pastor who have been treated with methylphenidate less than a year and not takenmethylphenidate/atomoxetine within four weeks of starting point of this study.

  • medication+Neurofeedback or medication+Sham treatment group include ADHDpatients undergoing methylphenidate or atomoxetine medication over the pastmonth without changes in capacity. And ADHD patients whose CGI-S scale is 4or higher.

Exclusion

Exclusion Criteria:

  • Patients diagnosed with congenital genetic disease

  • Patients with a clear history of acquired brain damage, such as cerebral palsy. ③Patients with convulsions, other neurological disorders, or uncorrected sensorydisorders

  • Patients with a history of schizophrenia, other childhood psychosis ⑤ IQbelow 80 ⑥ Patient with obsessive compulsive disorder, major depression orbipolar disorder

Study Design

Total Participants: 165
Study Start date:
July 07, 2020
Estimated Completion Date:
December 31, 2021

Connect with a study center

  • Seoul National University Childrens' Hospital

    Seoul, 110-744
    Korea, Republic of

    Active - Recruiting

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