Clinical trial NCT04469335: Effectiveness of a Mobile Neurofeedback for ADHD Youth
Official title: Comparative Clinical Trial With Double-blind Randomized Sham Control and Additive Treatment Toward Efficacy of Mobile Neurofeedback for ADHD Youth : An Exploratory Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Attention Deficit Hyperactivity Disorder
Lead sponsor: Seoul National University Childrens Hospital
Sponsor class: OTHER
Collaborators: name: Hanyang University
name: Wonkwang University Hospital
First posted: 2020-07-14
Enrollment: 165
Sex: ALL
Minimum age (years): 8
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Korean Attention Deficit Hyperactivity Disorder rating scale
timeFrame: baseline
measure: Korean Attention Deficit Hyperactivity Disorder rating scale
timeFrame: 2nd week
measure: Korean Attention Deficit Hyperactivity Disorder rating scale
timeFrame: 4th week
measure: Korean Attention Deficit Hyperactivity Disorder rating scale
timeFrame: 8th week
measure: Korean Attention Deficit Hyperactivity Disorder rating scale
timeFrame: third month
measure: Korean Attention Deficit Hyperactivity Disorder rating scale
timeFrame: sixth month
measure: Korean Attention Deficit Hyperactivity Disorder rating scale
timeFrame: twelfth month
measure: Clinical Global Impression Scale-Severity
timeFrame: baseline
measure: Clinical Global Impression Scale-Severity
timeFrame: 2nd week
measure: Clinical Global Impression Scale-Severity
timeFrame: 4th week
measure: Clinical Global Impression Scale-Severity
timeFrame: 8th week
measure: Clinical Global Impression Scale-Severity
timeFrame: third month
measure: Clinical Global Impression Scale-Severity
timeFrame: sixth month
measure: Clinical Global Impression Scale-Severity
timeFrame: twelfth month
measure: Children's Global Assessment Scale
timeFrame: baseline
measure: Children's Global Assessment Scale
timeFrame: 2nd week
measure: Children's Global Assessment Scale
timeFrame: 4th week
measure: Children's Global Assessment Scale
timeFrame: 8th week
measure: Children's Global Assessment Scale
timeFrame: third month
measure: Children's Global Assessment Scale
timeFrame: sixth month
measure: Children's Global Assessment Scale
timeFrame: twelfth month
Secondary outcomes:
measure: brain MRI
timeFrame: at the beginning, third month, sixth month, twelfth month
measure: EEG power in beta band
timeFrame: at the beginning, third month, sixth month, twelfth month
measure: EEG power in theta band
timeFrame: at the beginning, third month, sixth month, twelfth month
measure: Near Infra-Red Spectroscopy
timeFrame: at the beginning, third month, sixth month, twelfth month
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Childrens' Hospital
Study officials:
References: