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Trial registered on ANZCTR


Registration number
ACTRN12607000079448
Ethics application status
Approved
Date submitted
15/01/2007
Date registered
23/01/2007
Date last updated
23/01/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Alerting deficits in Children with Attention Deficit/Hyperactivity Disorder(ADHD) Revealed by functional Magnetic Resonance imaging(fMRI)
Scientific title
Naturalistic observation for alerting deficits in Children with Attention Deficit/Hyperactivity Disorder (ADHD) compare with normal controls by performing a cued target detection task during functional Magnetic Resonance imaging (fMRI)
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Children with ADHD 1571 0
Condition category
Condition code
Mental Health 1672 1672 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
During the state of nature (without any treatment or intervenes), 15 children with ADHD aged 11-16 years old, were asked to carry out a cued target detection task, in which participants were asked to respond to a white dot target, which could or could not be preceded by a star cue, during fMRI. The task lasted about 20 minutes.
Intervention code [1] 1559 0
None
Comparator / control treatment
During the state of nature (without any treatment or intervenes),15 normal controls, aged 11-16 years old, were asked to carry out a cued target detection task, in which participants were asked to respond to a white dot target, which could or could not be preceded by a star cue, during fMRI. The task lasted about 20 minutes.
Control group

Outcomes
Primary outcome [1] 2315 0
During this observational study, we measured the activation in frontal, parietal lobe and putamen during 20-minute alerting tasks in ADHD and normal control groups and compared the change of the blood oxygen level dependent (BOLD) signal in these areas between two groups.
Timepoint [1] 2315 0
Assessed in children with ADHD at baseline (without any treatment).
Secondary outcome [1] 4041 0
In this observational study, we measured the correlation of the ADHD symptoms severity for inattention and the change of the blood oxygen level dependent (BOLD) signal in the right precuneus in ADHD during 20-minute alerting tasks.
Timepoint [1] 4041 0
We assessed this outcome in children with ADHD at baseline (without any treatment).

Eligibility
Key inclusion criteria
1) right-handed, 2) Combined subtype of Attention Deficit/Hyperactivity Disorder (ADHD-C) or Attention Deficit/Hyperactivity Disorder predominantly inattentive type (ADHD-I)) and normal controls, 3) no history of emotional disorders, affective disorders, Tourette disorder and other Axis?psychiatric disorder.
Minimum age
11 Years
Maximum age
16 Years
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
The full scores of Wechsler Intelligence Scale for Chinese Children-Revised lower than 85.

Study design
Purpose
Psychosocial
Duration
Cross-sectional
Selection
Defined population
Timing
Both
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 472 0
China
State/province [1] 472 0

Funding & Sponsors
Funding source category [1] 1817 0
Government body
Name [1] 1817 0
The Key Project for Clinical Faculty Foundation, Ministry of Health
Address [1] 1817 0
Country [1] 1817 0
China
Primary sponsor type
Government body
Name
Ministry of Health, China
Address
Country
China
Secondary sponsor category [1] 1639 0
Government body
Name [1] 1639 0
Project of Science and Technology, Beijing
Address [1] 1639 0
Country [1] 1639 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3406 0
Research Ethics Review Board of Institute of Mental Health-Peking University
Ethics committee address [1] 3406 0
Ethics committee country [1] 3406 0
China
Date submitted for ethics approval [1] 3406 0
Approval date [1] 3406 0
Ethics approval number [1] 3406 0
S22

Summary
Brief summary
The aim of this study is to investigate the alerting functions deficits in children with ADHD using functional magnetic resonance imaging during the state of nature. We expect that the parietal lobe of ADHD showed lower activities than normal controls and the ADHD symptoms severity for inattention maybe correlate with the activities of parietal lobe in children with ADHD. This study will help us to further understand the pathology of ADHD.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27493 0
Address 27493 0
Country 27493 0
Phone 27493 0
Fax 27493 0
Email 27493 0
Contact person for public queries
Name 10748 0
Professor Yufeng Wang
Address 10748 0
Institute of Mental Health
Peking University
Huanyuanbeilu 51
Haidian District Beijing 100083
Country 10748 0
China
Phone 10748 0
+86 10 82801969
Fax 10748 0
+86 10 62761081
Email 10748 0
wangyf@bjmu.edu.cn
Contact person for scientific queries
Name 1676 0
Professor Yufeng Wang
Address 1676 0
Institute of Mental Health
Peking University
Huanyuanbeilu 51
Haidian District Beijing 100083
Country 1676 0
China
Phone 1676 0
+86 10 82801969
Fax 1676 0
+86 10 62761081
Email 1676 0
wangyf@bjmu.edu.cn

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary