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

    • Gelderland
      • 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

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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