Effectiveness of a Mobile Neurofeedback for ADHD Youth

S

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

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

Trial contacts and locations

1

Loading...

Central trial contact

Boong Nyun Kim, MD, PhD

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems