Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000547448
Ethics application status
Approved
Date submitted
19/10/2007
Date registered
24/10/2007
Date last updated
24/10/2007
Type of registration
Retrospectively registered

Titles & IDs
Public title
Dysfunction of the Fronto-Striatal-Insular Network in Attention Deficit Hyperactivity Disorder: A Resting-State functional Magnetic Resonance Imaging Study
Scientific title
Naturalistic observation for dysfucntion of the FSIT network in Children with Attention Deficit/Hyperactivity Disorder (ADHD) compare with normal controls during resting state functional Magnetic Resonance Imaging (rsfMRI)
Universal Trial Number (UTN)
Trial acronym
fMRI: functional Magnetic Resonance Imaging;
ADHD: Attention Deficit Hyperactivity Disorder
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Children with ADHD 2476 0
Condition category
Condition code
Mental Health 2577 2577 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
The goal of this study was to examine the resting-state functional connectivity within the fronto-striatal-insular network in subjects with ADHD and in healthy controls. Twenty-nine boys with ADHD engaged in resting-state fMRI scanning for 8 minutes during which they were instructed to lie with their eyes closed, think of nothing systematically, and not fall asleep.
Intervention code [1] 2206 0
Other interventions
Comparator / control treatment
Twenty-seven normal boys engaged in resting-state fMRI scanning for 8 minutes during which they were instructed to lie with their eyes closed, think of nothing systematically, and not fall asleep.
Control group
Active

Outcomes
Primary outcome [1] 3483 0
The reduced functional connectivity was mainly distributed among the right fronto-striatal-insular network (middle frontal gyrus, medial frontal gyrus, insula, paracentral lobule and superior frontal gyrus).
Timepoint [1] 3483 0
Assessed in neural network of children with ADHD at baseline (without any treatment).
Secondary outcome [1] 5815 0
Patients with ADHD had significantly less power in low-frequency oscillations (0.01 Hz ~ 0.1 Hz) in relation to healthy controls.
Timepoint [1] 5815 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
Sex
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
12/02/2005
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
56
Accrual to date
Final
Recruitment outside Australia
Country [1] 629 0
China
State/province [1] 629 0
Beijing
Country [2] 630 0
China
State/province [2] 630 0
Beijing

Funding & Sponsors
Funding source category [1] 2732 0
Government body
Name [1] 2732 0
the National Key Basic Research and Development Program
Country [1] 2732 0
China
Primary sponsor type
Government body
Name
the NSFC Chinese-Finnish NEURO program
Address
Department of National Science and Technology, Beijing
Country
China
Secondary sponsor category [1] 2468 0
Government body
Name [1] 2468 0
China Postdoctoral Science Foundation
Address [1] 2468 0
Department of National Education, Beijing
Country [1] 2468 0
China

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 4661 0
Research Ethics Review Board of Institute of Mental Health, Peaking University
Ethics committee address [1] 4661 0
Institute of Mental Health,
Peking University,
Beijing, PR China
Ethics committee country [1] 4661 0
China
Date submitted for ethics approval [1] 4661 0
12/02/2005
Approval date [1] 4661 0
12/02/2005
Ethics approval number [1] 4661 0
S22

Summary
Brief summary
The primary purpose of the present study was to use spatial ICA to identify differences in the resting-state functional connectivity of the fronto-striatal-insular network between healthy controls and patients with ADHD. We hypothesize that the pathophysiology of ADHD involves dysfunctional interaction or connectivity among regions of the fronto-striatal-insular network. ICA was used to calculate spatially independent, temporally synchronous regions (i.e., network) (Calhoun et al 2004); the fronto-striatal-insular network for each subject was selected using a spatial template to identify the network of interest. Study hypotheses were then tested by comparing the spatial-temporal characteristics of the fronto-striatal-insular network within and between groups.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28128 0
Address 28128 0
Country 28128 0
Phone 28128 0
Fax 28128 0
Email 28128 0
Contact person for public queries
Name 11285 0
Professor Yu-Feng Zang
Address 11285 0
State Key Laboratory of Cognitive Neuroscience and Learning
19, Xinjiekouwai Street, Suite 202
Beijing 100875, P.R. China
Country 11285 0
China
Phone 11285 0
+86 10 58802965
Fax 11285 0
+86 10 58806154
Email 11285 0
[email protected]
Contact person for scientific queries
Name 2213 0
Professor Yu-Feng Zang
Address 2213 0
State Key Laboratory of Cognitive Neuroscience and Learning
19, Xinjiekouwai Street, Suite 202
Beijing 100875, P.R. China
Country 2213 0
China
Phone 2213 0
+86 10 58802965
Fax 2213 0
+86 10 58806154
Email 2213 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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