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

ADHD Clinical Trial

— SHARK  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01932398
• Other study ID #: 3016038.01
• Status: Completed
• Phase: N/A
• First received: August 22, 2013
• Last updated: January 19, 2015
• Start date: November 2011
• Est. completion date: January 2015

Study information

• Verified date: January 2015
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 84 Months to 95 Months

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• ADHD

Locations

Country	Name	City	State
Netherlands	Donders Institute for Brain, Cognition and Behavior, Centre for Cognitive Neuroimaging	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	FSIQ estimation	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	No
Primary	Modualtion of alpha power	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	No
Secondary	Response time on covert attention task	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	No
Secondary	Standard deviation of response time on covert attention task	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	No
Secondary	Correct responses on covert attention task	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	No
Secondary	Mean deviation from middle on line bisection task	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	No
Secondary	Inattention score on the ADHD-RS-IV	The inattention subscale of the ADHD-RS-IV for 30 ADHD children and 30 non-ADHD children	Once in about 10 minutes	No
Secondary	Hyperactivity/impulsivity score on the ADHD-RS-IV	The hyperactivity/impulsivity subscale of the ADHD-RS-IV for 30 ADHD children and 30 non-ADHD children	Once in about 10 minutes	No