Pediatric Research on Improving Speed, Memory and Attention
PRISMA
The Efficacy of Neurofeedback to Improve Processing Speed, Attention and Memory in Childhood Brain Tumour Survivors: a Randomized Controlled Trial
2 other identifiers
interventional
105
1 country
1
Brief Summary
Introduction: 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). Approach: 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. Relevance: 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 18, 2009
CompletedFirst Posted
Study publicly available on registry
August 19, 2009
CompletedStudy Start
First participant enrolled
January 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedOctober 4, 2012
October 1, 2012
3.8 years
August 18, 2009
October 3, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Neurocognitive functioning
Before (T0) and after (T1) NFB training and 6 months follow up (T2)
Secondary Outcomes (1)
psychosocial functioning
T0, T1 and T2
Study Arms (3)
Neurofeedback
EXPERIMENTALChildren in this group receive 30 sessions of neurofeedback
Placebo feedback
SHAM COMPARATORThe children in this group receive 30 sessions of placebo feedback, based on muscular tension.
Siblings
NO INTERVENTIONThe siblings will be tested 1 time, they will function as a healthy control group.
Interventions
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.
Feedback based on a random signal generator and muscular tension instead of brain activity. 30 sessions at home, twice a week, total 15 weeks.
Eligibility Criteria
You may qualify if:
- Being treated for a brain tumour before the age of 16 years
- Age between 8-18 years at time of enrolment
- Off treatment at least two years
- Problems on attention, or memory or speed processing as reported by parents in screening test
- Being able to speak and understand the Dutch language
You may not qualify if:
- Premorbid AD/HD
- Mental or physical condition that make the neuropsychological assessment impossible to finish
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Academic Medical Centre - UvA
Amsterdam, North Holland, 1105AZ, Netherlands
Related Publications (1)
de Ruiter MA, Schouten-Van Meeteren AY, van Mourik R, Janssen TW, Greidanus JE, Oosterlaan J, Grootenhuis MA. Neurofeedback to improve neurocognitive functioning of children treated for a brain tumor: design of a randomized controlled double-blind trial. BMC Cancer. 2012 Dec 6;12:581. doi: 10.1186/1471-2407-12-581.
PMID: 23217162DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD
Study Record Dates
First Submitted
August 18, 2009
First Posted
August 19, 2009
Study Start
January 1, 2010
Primary Completion
October 1, 2013
Study Completion
July 1, 2014
Last Updated
October 4, 2012
Record last verified: 2012-10