Effectiveness of a Mobile Neurofeedback for ADHD Youth

Seoul National University Childrens Hospital

Status: Unknown

Conditions: Attention Deficit Hyperactivity Disorder

Treatments: Device: Sham mobile neurofeedback; Device: medication + Sham mobile neurofeedback; Device: medication + mobile neurofeedback; Device: mobile neurofeedback

Study type: Interventional

Funder types: Other

Identifiers

NCT04469335

1905-145-1035

Details and patient eligibility

About

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.

Enrollment: 165 estimated patients

Sex: All

Ages: 8 to 15 years old

Volunteers: No Healthy Volunteers

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 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.

Exclusion criteria

• Patients diagnosed with congenital genetic disease

  • 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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165 participants in 4 patient groups

mobile neurofeedback

Experimental group

Treatment:

Device: mobile neurofeedback

sham control

Sham Comparator group

Treatment:

Device: Sham mobile neurofeedback

medication +mobile neurofeedback

Experimental group

Treatment:

Device: medication + mobile neurofeedback

medication + sham control

Sham Comparator group

Treatment:

Device: medication + Sham mobile neurofeedback