NCT04629482

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 16, 2020

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2021

Completed
Last Updated

November 18, 2020

Status Verified

November 1, 2020

Enrollment Period

5 months

First QC Date

November 3, 2020

Last Update Submit

November 15, 2020

Conditions

Keywords

attention deficit hyperactivity disordernetworksmagnetoencephalographydevelopmental delaychildren

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (11)

  • Beery-Buktenica Visual-Motor Integration

    before magnetoencephalography examination

  • Sensory Profile Questionnaire

    before magnetoencephalography examination

  • Swanson, Nolan and Pelham

    before magnetoencephalography examination

  • +8 more other outcomes

Study Arms (2)

Children with attention deficit hyperactivity disorder with developmental delays

Children with attention deficit hyperactivity disorder with developmental delays

Other: Brain networks activity

Children with typical development

Children with typical development

Other: Brain networks activity

Interventions

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 attention deficit hyperactivity disorder with developmental delaysChildren with typical development

Eligibility Criteria

Age4 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-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

You may qualify if:

  • children with attention deficit hyperactivity disorder with development delays
  • intelligence quotient 70 or greater

You may not qualify if:

  • age less than 4 or greater than 10 of children
  • intelligence quotient less than 70

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, 111-01, Taiwan

Location

MeSH Terms

Conditions

Attention Deficit Disorder with HyperactivityLearning Disabilities

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior DisordersNeurodevelopmental DisordersMental DisordersCommunication DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ru-Lan Ru-Lan, MD

    Shin Kong Wu Ho-Su Memorial Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ru-Lan Hsieh, MD

CONTACT

Ru-Lan Hsieh, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 3, 2020

First Posted

November 16, 2020

Study Start

November 1, 2020

Primary Completion

March 31, 2021

Study Completion

March 31, 2021

Last Updated

November 18, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations