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Completed

NCT Number: NCT01932398

A Study on the Inter-Hemispheric Alpha Ratio in Kids With ADHD (SHARK)

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.

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Key information

Conditions

ADHD Attention Deficit Disorder with Hyperactivity Attention Deficit and Disruptive Behavior Disorders Mental Disorders Neurodevelopmental Disorders

Age range

84 month–95 month

Sex eligibility

All sexes

Study type

Observational

Primary location

Donders Institute for Brain, Cognition and Behavior, Centre for Cognitive Neuroimaging

Nijmegen, Gelderland, 6525 EN, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

Other outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Radboud University Medical Center

Other

Registry information

Official study title

Posterior Alpha Oscillations as an Index for the Attentional Bias in Children With Attentional Deficit Hyperactivity Disorder

Acronym: SHARK

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Aug 30, 2013
Registry last updated
Jan 21, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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