Brain ActivityNCT04629482
Brain Activity by Magnetoencephalography for Children
An observational study of Brain Activity, run by Taipei Medical University at 1 site in Taiwan.
Trial summary
Investigate the differences in activation of brain networks during performing functional tasks for children with attention deficit hyperactivity disorder with developmental delays and typical development Read more about this study
- Who is it for?
- Ages 4 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Activity
- What is being tested?
- Brain networks activity
- How many people
- 24 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2020to 31 Mar 2021
- Phase
- Observational
- 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 4 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Children diagnosed with attention deficit hyperactivity disorder with developmental delays, aged 4 to 10; and age-sex matched children with typical development
Who may be able to join
- children with attention deficit hyperactivity disorder with development delays
- intelligence quotient 70 or greater
Who cannot join
- age less than 4 or greater than 10 of children
- intelligence quotient less than 70
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Brain Network Activity of Functional Tasks Performance by Magnetoencephalography for Children
Investigate the differences in activation of brain networks during performing functional tasks for children with attention deficit hyperactivity disorder with developmental delays and typical development
Read the detailed description
A total of 12 children with attention deficit hyperactivity disorder with developmental delays and12 children with typical development will be enrolled.
The following evaluations will be evaluated by the investigator who is blinded to the group's classification.
Working task-related functions, such as Beery-Buktenica Visual-Motor Integration, Sensory Profile, the Chinese version of Swanson, Nolan and Pelham version IV, and Chinese version of Wechsler Intelligence Scale for Children-IV)
Non-working memory-related functions, such as Pediatric Outcome Data Collection Instrument (PODCI), Child Health Questionnaire- Parent Form (CHQ-PF 28), Pediatric Quality of Life Inventory (PedsQL), and physical function (10 meters normal and fast walking, stair ascent, stair descent, and 5 times chair rising and timed up and go test)
All participants will be investigated by magnetoencephalography and eye-tracking system to identify the difference of brain network activation during resting and performing tasks and between-group differences.
Brain magnetic resonance image study will be performed for matching of brain localization.
- Conditions
- Brain Activity
- Being tested
- Brain networks activity
- Keywords
- attention deficit hyperactivity disorder, networks, magnetoencephalography, developmental delay, children
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity, Learning Disabilities
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brain networks activityOther
The brain network activity under different conditions will be evaluated by magnetoencephalography, including resting, listen to different types of music, watch different types of videos, and interacting with cognitive stimulation conditions.
| Study group | Role | What they receive |
|---|---|---|
| Children with attention deficit hyperactivity disorder with developmental delays | Children with attention deficit hyperactivity disorder with developmental delays Receives: Other: Brain networks activity | |
| Children with typical development | Children with typical development Receives: Other: Brain networks activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Brain network activity by magnetoencephalograph
magnetoencephalography by different types of music
Measured: measure simultaneous brain activity by different types of music through study completion, up to 6 minutes
Brain network activity by magnetoencephalography
magnetoencephalography by different types of videos
Measured: measure simultaneous brain activity by different types of videos through study completion, up to 10.5 minutes
Brain network activity by magnetoencephalography
magnetoencephalography by different types of interactive cognitive stimulation
Measured: measure simultaneous brain activity by different types of interactive cognitive stimulation through study completion, up to 5 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2020
- Study startNov 2020 (estimated)
- Primary completion31 Mar 2021 (estimated)
- Study completion31 Mar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain ActivityStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ru-Lan Hsieh, Taipei Medical University
- Investigators
- Ru-Lan Ru-Lan, MD, Principal investigator, Shin Kong Wu Ho-Su Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04629482
- Sponsor's protocol ID
- 2020SKHADR035
- Status last verified
- Nov 2020
- First submitted
- 3 Nov 2020
- Last updated
- 18 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Brain Network Activity of Functional Tasks Performance by Magnetoencephalography for Children
- ClinicalTrials.gov ID
- NCT04629482
- Acronym / sponsor ID
- 2020SKHADR035
- Conditions
- Brain Activity
- Keywords
- attention deficit hyperactivity disorder, networks, magnetoencephalography, developmental delay, children
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Taipei Medical UniversityUniversity, hospital or other
- Study start
- Nov 2020 (estimated)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 16 Nov 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.
Investigate the differences in activation of brain networks during performing functional tasks for children with attention deficit hyperactivity disorder with developmental delays and typical development
Detailed description
A total of 12 children with attention deficit hyperactivity disorder with developmental delays and12 children with typical development will be enrolled.
The following evaluations will be evaluated by the investigator who is blinded to the group's classification.
Working task-related functions, such as Beery-Buktenica Visual-Motor Integration, Sensory Profile, the Chinese version of Swanson, Nolan and Pelham version IV, and Chinese version of Wechsler Intelligence Scale for Children-IV)
Non-working memory-related functions, such as Pediatric Outcome Data Collection Instrument (PODCI), Child Health Questionnaire- Parent Form (CHQ-PF 28), Pediatric Quality of Life Inventory (PedsQL), and physical function (10 meters normal and fast walking, stair ascent, stair descent, and 5 times chair rising and timed up and go test)
All participants will be investigated by magnetoencephalography and eye-tracking system to identify the difference of brain network activation during resting and performing tasks and between-group differences.
Brain magnetic resonance image study will be performed for matching of brain localization.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Children with attention deficit hyperactivity disorder with developmental delays | – | Other: Brain networks activityChildren with attention deficit hyperactivity disorder with developmental delays |
| Children with typical development | – | Other: Brain networks activityChildren with typical development |
Who may qualify
- Ages
- 4 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Children diagnosed with attention deficit hyperactivity disorder with developmental delays, aged 4 to 10; and age-sex matched children with typical development
Key inclusion criteria (2 listed)
- children with attention deficit hyperactivity disorder with development delays
- intelligence quotient 70 or greater
Key exclusion criteria (2 listed)
- age less than 4 or greater than 10 of children
- intelligence quotient less than 70
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 |
|---|---|---|
| Brain networks activityThe brain network activity under different conditions will be evaluated by magnetoencephalography, including resting, listen to different types of music, watch different types of videos, and interacting with cognitive stimulation conditions. | Other | Children with attention deficit hyperactivity disorder with developmental delays, Children with typical development |
Primary outcome
Brain network activity by magnetoencephalograph
Time frame: measure simultaneous brain activity by different types of music through study completion, up to 6 minutes
magnetoencephalography by different types of music
Brain network activity by magnetoencephalography
Time frame: measure simultaneous brain activity by different types of videos through study completion, up to 10.5 minutes
magnetoencephalography by different types of videos
Brain network activity by magnetoencephalography
Time frame: measure simultaneous brain activity by different types of interactive cognitive stimulation through study completion, up to 5 minutes
magnetoencephalography by different types of interactive cognitive stimulation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2020.
- Individual participant dataSharing planned: No
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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.
Ru-Lan Ru-Lan, MD principal investigator
Shin Kong Wu Ho-Su Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Activity, run by Taipei Medical University at 1 site in Taiwan.
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 2 inclusion and 2 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 18 Nov 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 Taiwan. 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. 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 Ru-Lan Hsieh, MD (886228332211 ext. 2531, M001052@ms.skh.org.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Brain network activity by magnetoencephalograph (time frame: measure simultaneous brain activity by different types of music through study completion, up to 6 minutes). The study lists 3 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 18 Nov 2020; AzTrials last refreshed its copy on 30 Oct 2026.