Pediatric Research on Improving Speed, Memory and Attention
NCT ID: NCT00961922
Last Updated: 2012-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
105 participants
INTERVENTIONAL
2010-01-31
2014-07-31
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Neurofeedback
Children in this group receive 30 sessions of neurofeedback
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.
Placebo feedback
The children in this group receive 30 sessions of placebo feedback, based on muscular tension.
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.
Siblings
The siblings will be tested 1 time, they will function as a healthy control group.
No interventions assigned to this group
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Mental or physical condition that make the neuropsychological assessment impossible to finish
8 Years
18 Years
ALL
No
Sponsors
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Dutch Cancer Society
OTHER
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
OTHER
Responsible Party
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Martha A. Grootenhuis
PhD
Locations
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Academic Medical Centre - UvA
Amsterdam, North Holland, Netherlands
Countries
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References
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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.
Other Identifiers
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MEC 09/137
Identifier Type: -
Identifier Source: secondary_id
UVA 2008-4013
Identifier Type: -
Identifier Source: org_study_id