Brain Activity by Magnetoencephalography for Children

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

Study Overview

• Status: Unknown
• Conditions: Brain Activity
• Intervention / Treatment: Other: Brain networks activity

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 Type: Observational
• Enrollment (Anticipated): 24

Contacts and Locations

• Study Contact: Name: Ru-Lan Hsieh, MD; Phone Number: 2531 886228332211; Email: M001052@ms.skh.org.tw
• Study Contact Backup: Name: Ru-Lan Hsieh, MD; Phone Number: 2531 886228662211; Email: M001052@ms.skh.org.tw

Study Locations

• Taiwan
  • Taipei, Taiwan, 111-01
    • Shin Kong Wu Ho-Su Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 10 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children diagnosed with attention deficit hyperactivity disorder with developmental delays, aged 4 to 10; and age-sex matched children with typical development

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Children with attention deficit hyperactivity disorder with developmental delays	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.
Children with typical development	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Beery-Buktenica Visual-Motor Integration	assess visual motor function	before magnetoencephalography examination
Sensory Profile Questionnaire	assess sensory integration,15 to 85, higher scores mean a better outcome	before magnetoencephalography examination
Swanson, Nolan and Pelham	assess the symptoms of attention deficit hyperactivity disorders, 0-78, higher scores mean a worse outcome	before magnetoencephalography examination
Wechsler Intelligence Scale for Children	assess the intelligence, 40-160, higher scores mean a better outcome	before magnetoencephalography examination
Pediatric Outcome Data Collection Instrument	assess the functional performance, 0-100, higher scores mean a better outcome	before magnetoencephalography examination
Child Health Questionnaire- Parent Form	assess the family impact, 0-100, higher scores mean a better outcome	before magnetoencephalography examination
Pediatric Quality of Life Inventory	assess the health-related quality of life, 0-100, higher scores mean a better outcome	before magnetoencephalography examination
10 meters walking speed	assess normal and fastest walking speed	before magnetoencephalography examination
stairs climbing time	assess ascent and descent stairs time	before magnetoencephalography examination
chair-rising time	assess 5 times of chair-rising time	before magnetoencephalography examination
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

Collaborators and Investigators

• Sponsor: Taipei Medical University
• Investigators: Principal Investigator: Ru-Lan Ru-Lan, MD, Shin Kong Wu Ho-Su Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2020
• Primary Completion (Anticipated): March 31, 2021
• Study Completion (Anticipated): March 31, 2021

Study Registration Dates

• First Submitted: November 3, 2020
• First Submitted That Met QC Criteria: November 9, 2020
• First Posted (Actual): November 16, 2020

Study Record Updates

• Last Update Posted (Actual): November 18, 2020
• Last Update Submitted That Met QC Criteria: November 15, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: children; attention deficit hyperactivity disorder; developmental delay; networks; magnetoencephalography
• Other Study ID Numbers: 2020SKHADR035

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No