Pediatric Research on Improving Speed, Memory and Attention (PRISMA)

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

Status: Unknown

Conditions: Brain Tumors

Treatments: Other: Placebo feedback; Other: Neurofeedback

Study type: Interventional

Funder types: Other

Identifiers

NCT00961922

UVA 2008-4013

MEC 09/137

Details and patient eligibility

About

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.

Enrollment: 105 estimated patients

Sex: All

Ages: 8 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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105 participants in 3 patient groups

Neurofeedback

Experimental group

Description:

Children in this group receive 30 sessions of neurofeedback

Treatment:

Other: Neurofeedback

Placebo feedback

Sham Comparator group

Description:

The children in this group receive 30 sessions of placebo feedback, based on muscular tension.

Treatment:

Other: Placebo feedback

Siblings

No Intervention group

Description:

The siblings will be tested 1 time, they will function as a healthy control group.