Pediatric Research on Improving Speed, Memory and Attention

Not Applicable

• Conditions: Brain Tumors
• Interventions: Other: Placebo feedback; Other: Neurofeedback

• Registration Number: NCT00961922
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-08-18
• Study First Submitted QC: 2009-08-18
• Study First Posted: 2009-08-19
• Study Start: 2010-01
• Status Verified: 2012-10
• Last Update Submitted: 2012-10-03
• Last Update Posted: 2012-10-04
• Primary Completion: 2013-10
• Study Completion: 2014-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 105

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo feedback	Placebo feedback	The children in this group receive 30 sessions of placebo feedback, based on muscular tension.
Neurofeedback	Neurofeedback	Children in this group receive 30 sessions of neurofeedback

Primary Outcome Measures

Name	Time	Method
Neurocognitive functioning	Before (T0) and after (T1) NFB training and 6 months follow up (T2)

Secondary Outcome Measures

Name	Time	Method
psychosocial functioning	T0, T1 and T2

Trial Locations

Locations (1)

Academic Medical Centre - UvA; 🇳🇱 Amsterdam, Noord Holland, Netherlands