PRISMA: Pediatric oncologic Research on Improving Speed, Memory and Attention
THE EFFICACY OF NEUROFEEDBACK TO IMPROVE ATTENTION AND MEMORY IN CHILDHOOD BRAIN TUMOUR SURVIVORS: A DOUBLE BLIND, RANDOMIZED, PLACEBO CONTROLLED TRIAL

In the Netherlands every year approximately 100 children are diagnosed with a
brain tumour. Nowadays five year survival rate for children with pediatric
brain tumours increased to 60-65%. The therapeutic successes achieved are a
result of advances in therapeutic regimens. These successes have a drawback,
more and more neurocognitive and psychosocial long-term consequences as a
result of the treatment for childhood cancer are reported. In particular
deficits in attention and memory are common, these are mostly found in children
treated for a brain tumour. The progress in medical care has gradually changed
the focus of research in pediatric psycho-oncology from descriptive
observational studies to intervention studies to reduce neurocognitive decline
of childhood cancer survivors (CCS). In the Netherlands much research has been
conducted at neuropsychological consequences of CCS. Research on interventions
is scarce, though we consider this of great importance.

The aim of this study is to investigate the efficacy of neurofeedback to
improve attention and memory in children that have been treated for a brain
tumour.
If the neurofeedback proves to be effective, we will strive to implement this
training for childhood cancer survivors with attentional problems. If
neurofeedback proves to be effective this is a big step forward to help this
vulnerable group of children.

We will conduct a double blind, randomized, placebo controlled trial.

Three groups, each consisting of N=35, total N=105:
1. The intervention group will receive 30 sessions of neurofeedback over the
course of 15 weeks.
2. The control group will receive 30 sessions of placebo feedback.
3. Healthy siblings, no intervention


Data will consist of:
- a QEEG for groups 1 and 2 as a baseline and to determine the appropriate
training for group 1 (see "primary outcomes")
- a neuropsychological assessment will be conducted in groups 1, 2 and 3 (see
"secondary outcomes")
- for groups 1, 2 and 3 data will be collected on behaviour and social
functioning.

Data will be collected at 3 testing moments:
- T0: Before the start of the intervention
- T1: After the last session of the intervention
- T2: 6 months after the last session of the intervention

If the neurofeedback proves to be effective, the control group will receive
neurofeedback training after this study is finished.

NFB is a therapy technique that presents the trainee with real-time feedback on
brainwave activity. Before the start of the NFB training a quantitative
electroencephalogram (QEEG) will be made. The QEEG detects and details the
source of the neurological inefficiency. The EEG signal is quantified and
statistically analyzed in comparison to a normative database.

The aim of the NFB is to establish conscious control of brainwave activity. If
brain activity changes in the direction desired by the selected training
protocol, a positive "reward" feedback is given to the individual, and if it
regresses, negative feedback is given, in the form of a video that stops
running. This principle is called operant conditioning for internal
functioning. Neurofeedback has proven to be effective in treatment of
attentional deficits in children with AD/HD (Attention Deficit Hyperactivity
Disorder). Participants are living all across the Netherlands. This made us
decide to train the children at their own homes using a portable NFB device.

NFB is een trainingsmethode voor de hersenen waarbij iemand kan leren om
controle te krijgen over zijn/haar hersengolven, door middel van het krijgen
van directe feedback over de hersengolven. Het proces begint bij het QEEG
(Quantitative ElectroEncephaloGram). Met het QEEG kan de bron van neurologische
inefficienties gevonden worden. Het EEG signaal wordt gekwantificeerd en
statistisch geanalyseerd in vergelijking met een normatieve database. Aan de
hand van een beslisboom wordt op basis van het QEEG gekeken welke training
gegeven gaat worden.
Bij de training zit de client in een stoel en kijkt naar een scherm waar een
filmpje op te zien is. Als de hersenactiviteit de door de geselecteerde
training gewenste frequentie vertoont gaat het filmpje lopen, dit is positieve
feedback. Als de hersenactiviteit niet de gewenste frequentie vertoont stopt
het filmpje en wordt het beeld zwart. Door deze terugkoppeling weet de client
wanneer er voldoende gewenste hersengolven geproduceerd worden en zal het brein
zich daar aan aanpassen (operante conditionering). NFB is effectief gebleken in
de behandeling van aandachtsproblematiek, met name bij kinderen met ADHD
(Attention Deficit Hyperactivity Disorder). Omdat de deelnemers door het hele
land wonen is gekozen om ze de training thuis te geven met draagbare
neurofeedback apparatuur.

The burden for the participants consists of:
- 3 times a half day in Amsterdam for the QEEG and the neuropsychological
testing
- 3 times filling out questionnaires online from home by the parent, the child
and the teacher, approximately 15 minutes each
- 30 sessions neurofeedback of one hour each at the child's home or school
- Total time approximately 10 months
There are no risks for the patients or their parents.