ADHDSHARKNCT01932398
A Study on the Inter-Hemispheric Alpha Ratio in Kids With ADHD (SHARK)
An observational study of ADHD, run by Radboud University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 84 to 95 monthsHealthy volunteers can take part
- Conditions the study is for
- ADHD
- Type of treatment
- Injection or infusion
- How many people
- 60 participants
- Where
- 1 siteNetherlands
- Study dates
- Nov 2011to Jan 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 84 to 95 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: ADHD vs no ADHD
Who may be able to join
- 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.
Who cannot join
- (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.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Donders Institute for Brain, Cognition and Behavior, Centre for Cognitive Neuroimaging
Nijmegen, Gelderland, 6525 EN
About this study
Official title: 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.
- Conditions
- ADHD
- Keywords
- Alpha, Lateralization, Attention, ADHD, Oscillation
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ADHD | A diagnosis of ADHD, classified by the DSM-IV. | |
| no ADHD | No diagnosis of ADHD, classified by the DSM-IV. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Once for half an hour
Secondary outcomes (6)
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
Measured: Once for half an hour
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
Measured: Once for half an hour
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
Measured: Once for half an hour
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
Measured: Once in about 5 minutes
Inattention score on the ADHD-RS-IV
The inattention subscale of the ADHD-RS-IV for 30 ADHD children and 30 non-ADHD children
Measured: Once in about 10 minutes
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
Measured: Once in about 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study startNov 2011
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ADHDStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ole Jensen, Prof, Principal investigator, Donders Institute for Brain, Cognition and Behavior - Centre for Cognitive NeuroimagingJan K Buitelaar, Prof, Principal investigator, Radboud University, Medical Centre - Donders Institute for Brain, Cognition and Behavior, Department of Cognitive Neuroscience
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01932398
- Sponsor's protocol ID
- 3016038.01
- Acronym
- SHARK
- Status last verified
- Jan 2015
- First submitted
- 22 Aug 2013
- Last updated
- 21 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Posterior Alpha Oscillations as an Index for the Attentional Bias in Children With Attentional Deficit Hyperactivity Disorder
- ClinicalTrials.gov ID
- NCT01932398
- Acronym / sponsor ID
- SHARK / 3016038.01
- Conditions
- ADHD
- Keywords
- Alpha, Lateralization, Attention, ADHD, Oscillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 30 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ADHD | – | –A diagnosis of ADHD, classified by the DSM-IV. |
| no ADHD | – | –No diagnosis of ADHD, classified by the DSM-IV. |
Who may qualify
- Ages
- 84 to 95 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- ADHD vs no ADHD
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
6 secondary outcomes
Response time on covert attention task
Time frame: Once for half an hour
Standard deviation of response time on covert attention task
Time frame: Once for half an hour
Correct responses on covert attention task
Time frame: Once for half an hour
Mean deviation from middle on line bisection task
Time frame: Once in about 5 minutes
Inattention score on the ADHD-RS-IV
Time frame: Once in about 10 minutes
Hyperactivity/impulsivity score on the ADHD-RS-IV
Time frame: Once in about 10 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ole Jensen, Prof principal investigator
Donders Institute for Brain, Cognition and Behavior - Centre for Cognitive Neuroimaging
Jan K Buitelaar, Prof principal investigator
Radboud University, Medical Centre - Donders Institute for Brain, Cognition and Behavior, Department of Cognitive Neuroscience
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ADHD, run by Radboud University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modualtion of alpha power (time frame: Once for half an hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jan 2015.