Attention Deficit Hyperactivity DisorderNCT04469335
Effectiveness of a Mobile Neurofeedback for ADHD Youth
A study testing mobile neurofeedback and medication + mobile neurofeedback in people with Attention Deficit Hyperactivity Disorder, run by Seoul National University Childrens Hospital at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 15 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- mobile neurofeedback and medication + mobile neurofeedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 165 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Jul 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Childrens' Hospital
Seoul, 110-744
Boong Nyun Kim, MD, PhD, +82-10-3637-1558, kbn1@snu.ac.kr
Boong Nyun Kim, MD, PhD
About this study
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.
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.
Read more
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.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- mobile neurofeedback, Sham mobile neurofeedback, medication + mobile neurofeedback, medication + Sham mobile neurofeedback
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile neurofeedbackDevice
to maximize usability and effectiveness, we would like to conduct a study that regulates theta/beta ratio using mobile app-based Neurofeedback Training Equipment (OmniCNS).
The actual Neurofeedback training allows you to download and use the omnifit brain_Game, an application with an audio guide. After the pre-assessment, the researcher will provide guidance to subjects and carers on how to use the application, and demonstrate how to use it in practice. For 2 weeks, 4 weeks and 6 weeks, phone calls are conducted to check whether they are used or not and for any inconvenience. After 12 weeks of Neurofeedback training, the device is returned and post-evaluated.
The application is equipped with four types of games and is instructed to use the three-day-a-week application. For Neurofeedback attention and cognitive training, use a headset with left and right frontal lobe 2 channel-EEG sensors to perform the game through feedback to see if it is concentrating well.
Sham mobile neurofeedbackDevice
It uses the sham devices and programs as the Neurofeedback, but it is not usually possible to obtain the expected effects of the Neurofeedback by providing random feedback regardless of actual brain waves.
In case of Sham control group, parental education is conducted the same for each clinical evaluation, and in case of Sham control group, actual Neurofeedback is applied if patients and parents want it after the end of the study.
medication + mobile neurofeedbackDevice
The mobile needback is applied to patients who are taking methylphenidate or atomoxetine, which is a standard ADHD treatment, but have not been remissioned with more than 4 points of CGI-S.
medication + Sham mobile neurofeedbackDevice
The sham mobile needback is applied to patients who are taking methylphenidate or atomoxetine, which is a standard ADHD treatment, but have not been remissioned with more than 4 points of CGI-S.
| Study group | Role | What they receive |
|---|---|---|
| mobile neurofeedback | Experimental | Not described Receives: Device: mobile neurofeedback |
| sham control | Sham comparator | Not described Receives: Device: Sham mobile neurofeedback |
| medication +mobile neurofeedback | Experimental | Not described Receives: Device: medication + mobile neurofeedback |
| medication + sham control | Sham comparator | Not described Receives: Device: medication + Sham mobile neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Korean Attention Deficit Hyperactivity Disorder rating scale
Measured: baseline
Korean Attention Deficit Hyperactivity Disorder rating scale
Measured: 2nd week
Korean Attention Deficit Hyperactivity Disorder rating scale
Measured: 4th week
Korean Attention Deficit Hyperactivity Disorder rating scale
Measured: 8th week
Korean Attention Deficit Hyperactivity Disorder rating scale
Measured: third month
Korean Attention Deficit Hyperactivity Disorder rating scale
Measured: sixth month
Korean Attention Deficit Hyperactivity Disorder rating scale
Measured: twelfth month
Clinical Global Impression Scale-Severity
Measured: baseline
Clinical Global Impression Scale-Severity
Measured: 2nd week
Clinical Global Impression Scale-Severity
Measured: 4th week
Clinical Global Impression Scale-Severity
Measured: 8th week
Clinical Global Impression Scale-Severity
Measured: third month
Clinical Global Impression Scale-Severity
Measured: sixth month
Clinical Global Impression Scale-Severity
Measured: twelfth month
Children's Global Assessment Scale
Measured: baseline
Children's Global Assessment Scale
Measured: 2nd week
Children's Global Assessment Scale
Measured: 4th week
Children's Global Assessment Scale
Measured: 8th week
Children's Global Assessment Scale
Measured: third month
Children's Global Assessment Scale
Measured: sixth month
Children's Global Assessment Scale
Measured: twelfth month
Secondary outcomes (4)
brain MRI
Measured: at the beginning, third month, sixth month, twelfth month
EEG power in beta band
Measured: at the beginning, third month, sixth month, twelfth month
EEG power in theta band
Measured: at the beginning, third month, sixth month, twelfth month
Near Infra-Red Spectroscopy
Measured: at the beginning, third month, sixth month, twelfth month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start7 Jul 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 165 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Childrens Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Hanyang University, Wonkwang University Hospital
- Responsible party
- Principal investigator, Booog Nyung Kim, Seoul National University Childrens Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04469335
- Sponsor's protocol ID
- 1905-145-1035
- Status last verified
- Jul 2020
- First submitted
- 7 Jul 2020
- Last updated
- 14 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04469335
- Acronym / sponsor ID
- 1905-145-1035
- Conditions
- Attention Deficit Hyperactivity Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 165 participants (estimated)
- Lead sponsor
- Seoul National University Childrens HospitalUniversity, hospital or other
- Collaborators
- Hanyang University, Wonkwang University Hospital
- Study start
- 7 Jul 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 14 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| mobile neurofeedback | Experimental | Device: mobile neurofeedback |
| sham control | Sham comparator | Device: Sham mobile neurofeedback |
| medication +mobile neurofeedback | Experimental | Device: medication + mobile neurofeedback |
| medication + sham control | Sham comparator | Device: medication + Sham mobile neurofeedback |
Who may qualify
- Ages
- 8 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- patient between the ages of 8 and 15
Key exclusion criteria (3 listed)
- Patients diagnosed with congenital genetic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| mobile neurofeedbackto maximize usability and effectiveness, we would like to conduct a study that regulates theta/beta ratio using mobile app-based Neurofeedback Training Equipment (OmniCNS). The actual Neurofeedback training allows you to download and use the omnifit brain_Game, an application with an audio guide. After the pre-assessment, the researcher will provide guidance to subjects and carers on how to use the application, and demonstrate how to use it in practice. For 2 weeks, 4 weeks and 6 weeks, phone calls are conducted to check whether they are used or not and for any inconvenience. After 12 weeks of Neurofeedback training, the device is returned and post-evaluated. The application is equipped with four types of games and is instructed to use the three-day-a-week application. For Neurofeedback attention and cognitive training, use a headset with left and right frontal lobe 2 channel-EEG sensors to perform the game through feedback to see if it is concentrating well. | Device | mobile neurofeedback |
| Sham mobile neurofeedbackIt uses the sham devices and programs as the Neurofeedback, but it is not usually possible to obtain the expected effects of the Neurofeedback by providing random feedback regardless of actual brain waves. In case of Sham control group, parental education is conducted the same for each clinical evaluation, and in case of Sham control group, actual Neurofeedback is applied if patients and parents want it after the end of the study. | Device | sham control |
| medication + mobile neurofeedbackThe mobile needback is applied to patients who are taking methylphenidate or atomoxetine, which is a standard ADHD treatment, but have not been remissioned with more than 4 points of CGI-S. | Device | medication +mobile neurofeedback |
| medication + Sham mobile neurofeedbackThe sham mobile needback is applied to patients who are taking methylphenidate or atomoxetine, which is a standard ADHD treatment, but have not been remissioned with more than 4 points of CGI-S. | Device | medication + sham control |
Primary outcome
Korean Attention Deficit Hyperactivity Disorder rating scale
Time frame: baseline
Korean Attention Deficit Hyperactivity Disorder rating scale
Time frame: 2nd week
Korean Attention Deficit Hyperactivity Disorder rating scale
Time frame: 4th week
Korean Attention Deficit Hyperactivity Disorder rating scale
Time frame: 8th week
Korean Attention Deficit Hyperactivity Disorder rating scale
Time frame: third month
Korean Attention Deficit Hyperactivity Disorder rating scale
Time frame: sixth month
Korean Attention Deficit Hyperactivity Disorder rating scale
Time frame: twelfth month
Clinical Global Impression Scale-Severity
Time frame: baseline
Clinical Global Impression Scale-Severity
Time frame: 2nd week
Clinical Global Impression Scale-Severity
Time frame: 4th week
Clinical Global Impression Scale-Severity
Time frame: 8th week
Clinical Global Impression Scale-Severity
Time frame: third month
Clinical Global Impression Scale-Severity
Time frame: sixth month
Clinical Global Impression Scale-Severity
Time frame: twelfth month
Children's Global Assessment Scale
Time frame: baseline
Children's Global Assessment Scale
Time frame: 2nd week
Children's Global Assessment Scale
Time frame: 4th week
Children's Global Assessment Scale
Time frame: 8th week
Children's Global Assessment Scale
Time frame: third month
Children's Global Assessment Scale
Time frame: sixth month
Children's Global Assessment Scale
Time frame: twelfth month
4 secondary outcomes
brain MRI
Time frame: at the beginning, third month, sixth month, twelfth month
EEG power in beta band
Time frame: at the beginning, third month, sixth month, twelfth month
EEG power in theta band
Time frame: at the beginning, third month, sixth month, twelfth month
Near Infra-Red Spectroscopy
Time frame: at the beginning, third month, sixth month, twelfth month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mobile neurofeedback and medication + mobile neurofeedback in people with Attention Deficit Hyperactivity Disorder, run by Seoul National University Childrens Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Boong Nyun Kim, MD, PhD (+82-10-3637-1558, kbn1@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Korean Attention Deficit Hyperactivity Disorder rating scale (time frame: baseline). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.