Pediatric Research on Improving Speed, Memory and Attention (PRISMA)
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|ClinicalTrials.gov Identifier: NCT00961922|
Recruitment Status : Unknown
Verified October 2012 by Martha A. Grootenhuis, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).
Recruitment status was: Active, not recruiting
First Posted : August 19, 2009
Last Update Posted : October 4, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain Tumors||Other: Neurofeedback Other: Placebo feedback||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||105 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Efficacy of Neurofeedback to Improve Processing Speed, Attention and Memory in Childhood Brain Tumour Survivors: a Randomized Controlled Trial|
|Study Start Date :||January 2010|
|Estimated Primary Completion Date :||October 2013|
|Estimated Study Completion Date :||July 2014|
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.
- Neurocognitive functioning [ Time Frame: Before (T0) and after (T1) NFB training and 6 months follow up (T2) ]
- psychosocial functioning [ Time Frame: T0, T1 and T2 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00961922
|Academic Medical Centre - UvA|
|Amsterdam, Noord Holland, Netherlands, 1105AZ|