Pediatric Research on Improving Speed, Memory and Attention (PRISMA)
The aim of this study is to investigate the efficacy of neurofeedback (NFB) to improve attention, memory and processing speed in children treated for a Brain Tumour (BT). In the Netherlands every year approximately 100 children are diagnosed with a BT. Nowadays over 65% of these children have a 5-year survival. Treatment for a BT consists of neurosurgery and / or local or craniospinal radiation and / or adjuvant chemotherapy. Neurotoxicity caused by radiotherapy and / or chemotherapy (especially methotrexate) is a major cause of neurocognitive decline in Childhood Brain Tumour Survivors (CBTS).
Studies have shown that NFB has the capacity to improve the brain systems mediating selective attention and response inhibition in children with Attention Deficit/Hyperactive Disorder (ADHD). The effectiveness is reported as comparable to methylphenidate (Ritalin) without side effects of medication. CBTS exhibit symptoms comparable to those of children with ADHD and positive response to methylphenidate has been found in CBTS. However, NFB has not been used as an intervention in CBTS yet. The effectiveness of NFB in children treated for a BT will be investigated in a randomized controlled trial. The intervention group of 30 patients will receive approximately 30 sessions of NFB; the control group will receive 30 session of placebo neurofeedback. Neuropsychological tests will be used to evaluate pre- and post-NFB intervention as well as at a 6-month follow-up.
If NFB proofs to be effective for CBTS this will be a great improvement for their (neuro-) psychological functioning and quality of life, without the disadvantage of the side effects of medication. The implementation of this intervention might increase cognitive and social functioning and thus facilitate integration of these children in society during childhood and school carrier as well as in adult life.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||The Efficacy of Neurofeedback to Improve Processing Speed, Attention and Memory in Childhood Brain Tumour Survivors: a Randomized Controlled Trial|
- Neurocognitive functioning [ Time Frame: Before (T0) and after (T1) NFB training and 6 months follow up (T2) ] [ Designated as safety issue: No ]
- psychosocial functioning [ Time Frame: T0, T1 and T2 ] [ Designated as safety issue: No ]
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||July 2014|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
Children in this group receive 30 sessions of neurofeedback
30 sessions of neurofeedback will be given twice a week at the child's home. It will take about 15 weeks to complete the training.
Sham Comparator: Placebo feedback
The children in this group receive 30 sessions of placebo feedback, based on muscular tension.
Other: Placebo feedback
Feedback based on a random signal generator and muscular tension instead of brain activity. 30 sessions at home, twice a week, total 15 weeks.
No Intervention: Siblings
The siblings will be tested 1 time, they will function as a healthy control group.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00961922
|Academic Medical Centre - UvA|
|Amsterdam, Noord Holland, Netherlands, 1105AZ|