Brain Activity by Magnetoencephalography for Children

Brain Activity Clinical Trial

Official title:

The Brain Network Activity of Functional Tasks Performance by Magnetoencephalography for Children

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04629482
• Other study ID #: 2020SKHADR035
• Status: Not yet recruiting
• Start date: November 2020
• Est. completion date: March 31, 2021

Study information

• Verified date: November 2020
• Source: Taipei Medical University
• Contact: Ru-Lan Hsieh, MD
• Phone: 886228332211
• Email: M001052[@]ms.skh.org.tw
• Is FDA regulated: No
• Study type: Observational

Clinical 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: March 31, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 10 Years

Eligibility

Inclusion Criteria:

• children with attention deficit hyperactivity disorder with development delays

• intelligence quotient 70 or greater

Exclusion Criteria:

• age less than 4 or greater than 10 of children

• intelligence quotient less than 70

Related Conditions & MeSH terms

• Brain Activity

Intervention

Other:
• Brain networks activity
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.

Locations

Country	Name	City	State
Taiwan	Shin Kong Wu Ho-Su Memorial Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Beery-Buktenica Visual-Motor Integration	assess visual motor function	before magnetoencephalography examination
Other	Sensory Profile Questionnaire	assess sensory integration,15 to 85, higher scores mean a better outcome	before magnetoencephalography examination
Other	Swanson, Nolan and Pelham	assess the symptoms of attention deficit hyperactivity disorders, 0-78, higher scores mean a worse outcome	before magnetoencephalography examination
Other	Wechsler Intelligence Scale for Children	assess the intelligence, 40-160, higher scores mean a better outcome	before magnetoencephalography examination
Other	Pediatric Outcome Data Collection Instrument	assess the functional performance, 0-100, higher scores mean a better outcome	before magnetoencephalography examination
Other	Child Health Questionnaire- Parent Form	assess the family impact, 0-100, higher scores mean a better outcome	before magnetoencephalography examination
Other	Pediatric Quality of Life Inventory	assess the health-related quality of life, 0-100, higher scores mean a better outcome	before magnetoencephalography examination
Other	10 meters walking speed	assess normal and fastest walking speed	before magnetoencephalography examination
Other	stairs climbing time	assess ascent and descent stairs time	before magnetoencephalography examination
Other	chair-rising time	assess 5 times of chair-rising time	before magnetoencephalography examination
Other	timed up and go	assess time for stand up from a chair, go around for 3 meters, and sit down to chair	before magnetoencephalography examination
Primary	Brain network activity by magnetoencephalograph	magnetoencephalography by different types of music	measure simultaneous brain activity by different types of music through study completion, up to 6 minutes
Primary	Brain network activity by magnetoencephalography	magnetoencephalography by different types of videos	measure simultaneous brain activity by different types of videos through study completion, up to 10.5 minutes
Primary	Brain network activity by magnetoencephalography	magnetoencephalography by different types of interactive cognitive stimulation	measure simultaneous brain activity by different types of interactive cognitive stimulation through study completion, up to 5 minutes