Brain Activity by Magnetoencephalography for Children

Sponsor
Taipei Medical University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04629482
Collaborator
(none)
24
1
4.9
4.9

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
24 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
The Brain Network Activity of Functional Tasks Performance by Magnetoencephalography for Children
Anticipated Study Start Date :
Nov 1, 2020
Anticipated Primary Completion Date :
Mar 31, 2021
Anticipated Study Completion Date :
Mar 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Children with attention deficit hyperactivity disorder with developmental delays

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

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.

Outcome Measures

Primary Outcome Measures

  1. Brain network activity by magnetoencephalograph [measure simultaneous brain activity by different types of music through study completion, up to 6 minutes]

    magnetoencephalography by different types of music

  2. Brain network activity by magnetoencephalography [measure simultaneous brain activity by different types of videos through study completion, up to 10.5 minutes]

    magnetoencephalography by different types of videos

  3. Brain network activity by magnetoencephalography [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

Other Outcome Measures

  1. Beery-Buktenica Visual-Motor Integration [before magnetoencephalography examination]

    assess visual motor function

  2. Sensory Profile Questionnaire [before magnetoencephalography examination]

    assess sensory integration,15 to 85, higher scores mean a better outcome

  3. Swanson, Nolan and Pelham [before magnetoencephalography examination]

    assess the symptoms of attention deficit hyperactivity disorders, 0-78, higher scores mean a worse outcome

  4. Wechsler Intelligence Scale for Children [before magnetoencephalography examination]

    assess the intelligence, 40-160, higher scores mean a better outcome

  5. Pediatric Outcome Data Collection Instrument [before magnetoencephalography examination]

    assess the functional performance, 0-100, higher scores mean a better outcome

  6. Child Health Questionnaire- Parent Form [before magnetoencephalography examination]

    assess the family impact, 0-100, higher scores mean a better outcome

  7. Pediatric Quality of Life Inventory [before magnetoencephalography examination]

    assess the health-related quality of life, 0-100, higher scores mean a better outcome

  8. 10 meters walking speed [before magnetoencephalography examination]

    assess normal and fastest walking speed

  9. stairs climbing time [before magnetoencephalography examination]

    assess ascent and descent stairs time

  10. chair-rising time [before magnetoencephalography examination]

    assess 5 times of chair-rising time

  11. timed up and go [before magnetoencephalography examination]

    assess time for stand up from a chair, go around for 3 meters, and sit down to chair

Eligibility Criteria

Criteria

Ages Eligible for Study:
4 Years to 10 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Shin Kong Wu Ho-Su Memorial Hospital Taipei Taiwan 111-01

Sponsors and Collaborators

  • Taipei Medical University

Investigators

  • Principal Investigator: Ru-Lan Ru-Lan, MD, Shin Kong Wu Ho-Su Memorial Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Ru-Lan Hsieh, Professor, Taipei Medical University
ClinicalTrials.gov Identifier:
NCT04629482
Other Study ID Numbers:
  • 2020SKHADR035
First Posted:
Nov 16, 2020
Last Update Posted:
Nov 18, 2020
Last Verified:
Nov 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ru-Lan Hsieh, Professor, Taipei Medical University

Study Results

No Results Posted as of Nov 18, 2020