- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01932398
A Study on the Inter-Hemispheric Alpha Ratio in Kids With ADHD (SHARK) (SHARK)
January 19, 2015 updated by: Radboud University Medical Center
Posterior Alpha Oscillations as an Index for the Attentional Bias in Children With Attentional Deficit Hyperactivity Disorder
Investigate the hypothesis that children with ADHD have difficulty with the allocation of visio-spatial attention related to an inability to control posterior alpha brain oscillations.
A paradigm will be used in which the aim is to address covert attention as similar recent studies did in adults with ADHD.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Gelderland
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Nijmegen, Gelderland, Netherlands, 6525 EN
- Donders Institute for Brain, Cognition and Behavior, Centre for Cognitive Neuroimaging
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years to 7 years (CHILD)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
ADHD vs no ADHD
Description
Inclusion Criteria:
For both groups
- Age between 7 and 10 years of age.
- Estimated IQ above 80.
- Psychopharmaca- naïve or -free.
For the ADHD-group - A diagnosis of ADHD, classified by the DSM-IV.
Exclusion Criteria:
- (Co-morbid) psychiatric disorder (major depression, bipolar disorder, psychotic disorder, chronically motor tic disorder or Gilles de la Tourette, Conduct disorder, autism spectrum disorder, eating disorder, anxiety disorder).
- Neurological disorders (e.g. epilepsy) currently or in the past.
- Cardiovascular disease currently or in the past.
- Serious motor or perceptual handicap.
For the no ADHD-group
- No diagnosis of ADHD, classified by the DSM-IV.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
ADHD
A diagnosis of ADHD, classified by the DSM-IV.
|
no ADHD
No diagnosis of ADHD, classified by the DSM-IV.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Modualtion of alpha power
Time Frame: Once for half an hour
|
Modulation* of alpha power on congruent and incongruent trials of the covert attention task in 30 ADHD children and in 30 non-ADHD children *Modulation is the (expected) cue-induced change by a covert attention task. |
Once for half an hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Response time on covert attention task
Time Frame: Once for half an hour
|
Time it takes to press the correct button after presentation of target-stimulus on congruent and incongruent trials of the covert attention task in 30 ADHD children and 30 non-ADHD children
|
Once for half an hour
|
Standard deviation of response time on covert attention task
Time Frame: Once for half an hour
|
The variation of the time it takes to press the correct button after presentation of target-stimulus on congruent and incongruent trials of the covert attention task in 30 ADHD children and 30 non-ADHD children
|
Once for half an hour
|
Correct responses on covert attention task
Time Frame: Once for half an hour
|
Number of correct button presses responses (i.e.
same side as the target) on the covert attention task on congruent and incongruent trials of the covert attention task in 30 ADHD children and 30 non-ADHD children
|
Once for half an hour
|
Mean deviation from middle on line bisection task
Time Frame: Once in about 5 minutes
|
Mean deviation in mm from the center of the line on the line bisection task for 30 ADHD children and 30 non-ADHD children
|
Once in about 5 minutes
|
Inattention score on the ADHD-RS-IV
Time Frame: Once in about 10 minutes
|
The inattention subscale of the ADHD-RS-IV for 30 ADHD children and 30 non-ADHD children
|
Once in about 10 minutes
|
Hyperactivity/impulsivity score on the ADHD-RS-IV
Time Frame: Once in about 10 minutes
|
The hyperactivity/impulsivity subscale of the ADHD-RS-IV for 30 ADHD children and 30 non-ADHD children
|
Once in about 10 minutes
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
FSIQ estimation
Time Frame: Once in about 20 minutes
|
An estimate of full scale IQ, measured with 2 subtests of the WISC-III for 30 ADHD-children and 30 non-ADHD children
|
Once in about 20 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Ole Jensen, Prof, Donders Institute for Brain, Cognition and Behavior - Centre for Cognitive Neuroimaging
- Principal Investigator: Jan K Buitelaar, Prof, Radboud University, Medical Centre - Donders Institute for Brain, Cognition and Behavior, Department of Cognitive Neuroscience
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2011
Primary Completion (ACTUAL)
January 1, 2015
Study Completion (ACTUAL)
January 1, 2015
Study Registration Dates
First Submitted
August 22, 2013
First Submitted That Met QC Criteria
August 27, 2013
First Posted (ESTIMATE)
August 30, 2013
Study Record Updates
Last Update Posted (ESTIMATE)
January 21, 2015
Last Update Submitted That Met QC Criteria
January 19, 2015
Last Verified
January 1, 2015
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 3016038.01
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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