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Clinical Trials/NCT00961922
NCT00961922
Unknown
Not Applicable

The Efficacy of Neurofeedback to Improve Processing Speed, Attention and Memory in Childhood Brain Tumour Survivors: a Randomized Controlled Trial

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)1 site in 1 country105 target enrollmentJanuary 2010
ConditionsBrain Tumors

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Brain Tumors
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Enrollment
105
Locations
1
Primary Endpoint
Neurocognitive functioning
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2010
End Date
July 2014
Last Updated
13 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Martha A. Grootenhuis

PhD

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • Premorbid AD/HD
  • Mental or physical condition that make the neuropsychological assessment impossible to finish

Outcomes

Primary Outcomes

Neurocognitive functioning

Time Frame: Before (T0) and after (T1) NFB training and 6 months follow up (T2)

Secondary Outcomes

  • psychosocial functioning(T0, T1 and T2)

Study Sites (1)

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