|- candidate number||13187|
|- NTR Number||NTR3551|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||31-jul-2012|
|- Secondary IDs||NL41630.044.12 CCMO|
|- Public Title||Do ADHD and frontal epilepsy have the same characteristics?|
|- Scientific Title||Distinguishing children with frontal epilepsy from children with ADHD in terms of executive functioning.|
|- hypothesis||Children with frontal epilepsy have more executive functionproblems then children with ADHD.|
|- Healt Condition(s) or Problem(s) studied||Frontal lobe epilepsy, ADHD, Executive functioning|
|- Inclusion criteria||1. Children aged 8-12 years;|
2. Diagnosed with frontal lobe epilepsy or ADHD as diagnosed by the DSM-IV criteria (American Psychiatric Association, 2000);
3. IQ > 70 (testing no older than 2 years) or if not tested before academic scores not lower then C (CITO);
4. Ability to understand and read Dutch.
|- Exclusion criteria||1. Coexisting psychiatric disorder as diagnosed by the DSM-IV criteria (American Psychiatric Association, 2000);|
2. Coexisting medical disease which can influence testing;
3. Treatment with psychiatric medication which can influence testing;
4. Specific epilepsy syndromes in which children can deteriorate.
|- mec approval received||no|
|- multicenter trial||no|
|- Type||2 or more arms, non-randomized|
|- planned startdate ||1-sep-2012|
|- planned closingdate||1-sep-2014|
|- Target number of participants||80|
|- Interventions||Neuropsychological testing.|
|- Primary outcome||Working memory.|
|- Secondary outcome||1. Cognitive flexibility;|
2. Sustained attention;
4. Working pace;
|- Timepoints||Working memory: |
This will be assessed using digit span of the WISC-III-NL (Wechsler, 2005) and two tests of the FEPSY: recognition task and corsi block (Moerland, Aldenkamp, Alpherts, 1988).
This will be assessed using one test of the FEPSY: classification (Moerland et al. 1988).
This will be assessed using the Stroop (Ridley, 1935) and two tests of the FEPSY: bkg & srt (Moerland et al. 1988).
This will be assesses using one test of the FEPSY: vigilance (Moerland et al. 1988).
Visual and auditory reaction times will be measured using the FEPSY: reaction times; motor speed will be measured using the FEPSY: tapping (Moerland et al. 1988).
Both parents and teacher will complete the following questionnaires to asses behaviour:
1. BRIEF (Smidts & Huizinga, 2009);
2. CBCL (Verhulst, van der Ende & Koot, 1996);
3. TRF (Verhulst, van der Ende & Koot, 1997);
4. AVL (Scholte & van der Ploeg, 1999).
Parenting style and interaction: a structured clinical interview (needs to be developed).
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| L. Berg, van den|
|- CONTACT for SCIENTIFIC QUERIES|| L. Berg, van den|
|- Sponsor/Initiator ||SEIN|
(Source(s) of Monetary or Material Support)
|- Brief summary||ADHD is a behavioural diagnosis, while frontal lobe epilepsy is a medical diagnosis. However, children with frontal lobe epilepsy show cognitive problems, resulting in learning and behavioural problems, which are also seen in children with ADHD. Those problems mainly involve executive dysfunction (working memory, cognitive flexibility, inhibition, sustained attention and working pace). Usually, children with frontal epilepsy and children with ADHD receive similar advice and treatment, sometimes with medication for behavioural problems. Some children have both diagnoses. There are many studies to distinguish epilepsy in general from ADHD. Yet, studies to give insight in the neuropsychological profile of children with frontal epilepsy are rare, let alone studies to distinguish children with frontal lobe epilepsy from children with ADHD in terms of executive functioning. Studies hypothesise that there is a difference between those groups and that further research is needed. Other studies, where ADHD behaviour in other neurological disorders have been compared to ADHD, showed a difference between the two.|
|- Main changes (audit trail)|
|- RECORD||31-jul-2012 - 8-sep-2012|