Pediatric Research on Improving Speed, Memory and Attention

Brain Tumors Clinical Trial

— PRISMA  

Official title:

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

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00961922
• Other study ID #: UVA 2008-4013
• Secondary ID: MEC 09/137
• Status: Unknown status
• Phase: N/A
• First received: August 18, 2009
• Last updated: October 3, 2012
• Start date: January 2010
• Est. completion date: July 2014

Study information

• Verified date: October 2012
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 105
• Est. completion date: July 2014
• Est. primary completion date: October 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Neoplasms
• Brain Tumors

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Netherlands	Academic Medical Centre - UvA	Amsterdam	Noord Holland

Sponsors (2)

Lead Sponsor	Collaborator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)	Dutch Cancer Society

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neurocognitive functioning		Before (T0) and after (T1) NFB training and 6 months follow up (T2)
Secondary	psychosocial functioning		T0, T1 and T2