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On the relationship between brain structure and oscillatory activity in ADHD children


- candidate number26730
- NTR NumberNTR6304
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR20-feb-2017
- Secondary IDsNL56007.091.15 METC
- Public Title On the relationship between brain structure and oscillatory activity in ADHD children
- Scientific Title On the relationship between brain structure and oscillatory activity in ADHD children
- ACRONYMSHARK2
- hypothesisWithin the domain of spatial attention, it has been shown that changes in neuronal synchronization are fundamental to implement the mechanisms required for selective gating. Specifically, modulations in both the alpha (8-13Hz) and gamma band (30-90Hz) are predictive of performance in spatial attention tasks. Studies have reported that patients with Attention Deficit and Hyperactivity Disorder (ADHD) show a reduced ability to modulate alpha and gamma band oscillations during covert attention, when compared to controls. Stimulant medications (e.g. Methylphenidate) often provide effective treatment for ADHD symptoms, while little is known about the neuronal mechanisms by which they exert their effect. Given the role of neuronal oscillatory modulations in attentional performance, pharmacological intervention is expected to normalize the eventual differences in alpha and gamma band synchronization between ADHD patients and healthy subjects. Furthermore, investigation of anatomical differences between the two groups is performed to identify the brain structures responsible for top-down attentional modulation.
- Healt Condition(s) or Problem(s) studiedADHD
- Inclusion criteriacontrols
- 8-12 years old
- male
- no psychiatric dysorder
- IQ >80


ADHD
- diagnosis of ADHD (DSM IV)
- score in clinical range of ADHD rating scale
- Pharmacological treatment with Stimulant medication for the treatment of ADHD (either long- or shortacting formulations), which started at least 3 months before the inclusion in the study.
- Exclusion criteria(1) Neurological disorders (e.g. epilepsy) currently or in the past.
(2) Cardiovascular disease currently or in the past.
(3) Serious motor or perceptual handicap.
(4) Standard MRI Exclusion criteria according to DCCN regulations.

The presence of comorbid symptoms will be documented: for the control group, by scores for problem behaviours on the Childhood Behavior Checklist (CBCL) , completed by the parents; For the ADHD group a psychiatrist from the Karakter Instituut will perform a clinical evaluation assessing eventual comorbities.
- mec approval receivedyes
- multicenter trialno
- randomisedyes
- masking/blindingDouble
- controlPlacebo
- groupCrossover
- Type2 or more arms, randomized
- Studytypeobservational
- planned startdate 1-sep-2016
- planned closingdate
- Target number of participants60
- Interventionson/off medication (placebo / active medication(methykphenidate)) for the ADHD group. no intervention for control group.
- Primary outcome-alpha modulation during attyentional performance
- striatal brain volume
- Superior Liongitudinal Fasciculus asymmetry
- Secondary outcomena
- Timepoints- variables measured during experiment
for ADHD, MEG and MRI data measured on and off (placebo) medication (1 week between two recordings)
- Trial web site
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES C Mazzetti
- CONTACT for SCIENTIFIC QUERIES C Mazzetti
- Sponsor/Initiator Donders Institute for Brain, Cognition, and Behaviour, Centre for Cognition, Radboud University Nijmegen
- Funding
(Source(s) of Monetary or Material Support)
Marie Slodowska Curie
- Publications
- Brief summaryWithin the domain of spatial attention, it has been shown that changes in neuronal synchronization are fundamental to implement the mechanisms required for selective gating. Specifically, modulations in both the alpha (8-13Hz) and gamma band (30-90Hz) are predictive of performance in spatial attention tasks. Studies have reported that patients with Attention Deficit and Hyperactivity Disorder (ADHD) show a reduced ability to modulate alpha band oscillations during covert attention, when compared to controls5. Stimulant medications (e.g. Methylphenidate) often provide effective treatment for ADHD symptoms, while little is known about the neuronal mechanisms by which they exert their effect. Given the role of neuronal oscillatory modulations in attentional performance, pharmacological intervention is expected to normalize the eventual differences in alpha and gamma band synchronization between ADHD patients and healthy subjects. Furthermore, investigation of anatomical differences between the two groups is performed to identify the brain structures responsible for top-down attentional modulation.
- Main changes (audit trail)
- RECORD20-feb-2017 - 19-mei-2017


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