|- candidate number||9326|
|- NTR Number||NTR2848|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||14-apr-2011|
|- Secondary IDs||NL29647.068.10 ABR Number|
|- Public Title||QEEG profiles in developmental disorders.|
|- Scientific Title||QEEG measurements to help identify developmental disorders in children.|
|- hypothesis||1. QEEG markers can differentiate a developmental disorder, in this case ADHD and ASD, not only from a control group but also from each other;|
2. QEEG markers are associated with the change in behavioural characteristics after administration of methylphenidate in patients with ADHD.
|- Healt Condition(s) or Problem(s) studied||Developmental disorder, ADHD, Autism Spectrum Disorders (ASDs), QEEG|
|- Inclusion criteria||1. Boys between 6 and 12 years with the diagnosis of ADHD or ASD conform DSM-IV criteria, with or without co-morbidities like Gilles de la Tourette, DCD or dyslexia;|
2. Control group of healthy boys between 6 and 12 years.
|- Exclusion criteria||1. Children with organic brain-defects, epilepsy, migraine, other psychiatric disorders than developmental disorders and children with influenza or fever;|
2. Besides the boys in the control group should not have a developmental disorder.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-sep-2011|
|- planned closingdate||1-sep-2015|
|- Target number of participants||110|
|- Interventions||QEEG measurements under four conditions:|
1. Resting with eyes open;
2. Resting with eyes closed;
3. During an attention task;
4. During a motor task.
Parents will have to complete two questionnaires (SDQ and ADHD-Rating Scale). Boys with ADHD who are taking methylphenidate are measured twice: once on a day with medication and once on a day without methylphenidate.
|- Primary outcome||QEEG-signals of twenty electrodes, measured as the average contribution in microvolt of each frequency band on each electrode in four different conditions.|
|- Secondary outcome||QEEG-signals in boys with ADHD, measured on a day with methylphenidate medication and on a day without, compared with their behavioural characteristics as measured by the ADHD-Rating Scale.|
|- Timepoints||The total time of the measurements will be 45 tot 60 minutes for each child.|
In boys with ADHD, who are taking methylphenidate, the second measurement without medication will be conducted within four weeks.
|- Trial web site||Specific page on hospital website: www.viecuri.nl|
|- CONTACT FOR PUBLIC QUERIES|| A. Driessen|
|- CONTACT for SCIENTIFIC QUERIES|| Ton Haagen|
|- Sponsor/Initiator ||VieCuri Medisch Centrum voor Noord-Limburg|
(Source(s) of Monetary or Material Support)
|- Publications||`Effects of a restricted elimination diet on the behaviour of children with attention/deficit hyperactivity disorder )INCA study: a randomised controlled trial`|
Lidy M.Pelser et al. The Lancet, Volume 377, Issue 9764, Pages 494/503, 5 February 2011.
|- Brief summary||The main aim of this study is to search for sensitive and specific QEEG markers to differentiate between children with a developmental disorder, in this case ADHD and ASD, and a control group and to differentiate between these two developmental disorders compared with each other. To do so, the patient groups and the control group are measured with the same equipment, software and measure settings. In this way QEEG outcome across groups can be compared in a reliable and valid way. By means of combining several (non)linear analysis methods QEEG markers for every pathology will be examined and developed and sensitivity and specificity measures of these markers will be calculated.
Additionally the effect of medication (methylphenidate) in children with ADHD on the QEEG profile will be investigated.|
|- Main changes (audit trail)|
|- RECORD||14-apr-2011 - 20-apr-2011|