Overview

This trial is active, not recruiting.

Condition brain tumors
Treatments neurofeedback, placebo feedback
Sponsor Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborator Dutch Cancer Society
Start date January 2010
End date October 2013
Trial size 105 participants
Trial identifier NCT00961922, MEC 09/137, UVA 2008-4013

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
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.
(Sham Comparator)
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.
(No Intervention)
The siblings will be tested 1 time, they will function as a healthy control group.

Primary Outcomes

Measure
Neurocognitive functioning
time frame: Before (T0) and after (T1) NFB training and 6 months follow up (T2)

Secondary Outcomes

Measure
psychosocial functioning
time frame: T0, T1 and T2

Eligibility Criteria

Male or female participants from 8 years up to 18 years old.

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

Additional Information

Official title The Efficacy of Neurofeedback to Improve Processing Speed, Attention and Memory in Childhood Brain Tumour Survivors: a Randomized Controlled Trial
Trial information was received from ClinicalTrials.gov and was last updated in October 2012.
Information provided to ClinicalTrials.gov by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA).