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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Dutch Cancer Society
Information provided by (Responsible Party):
Martha A. Grootenhuis, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier:
NCT00961922
First received: August 18, 2009
Last updated: October 3, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Brain Tumors
Other: Neurofeedback
Other: Placebo feedback

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Efficacy of Neurofeedback to Improve Processing Speed, Attention and Memory in Childhood Brain Tumour Survivors: a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):

Primary Outcome Measures:
  • Neurocognitive functioning [ Time Frame: Before (T0) and after (T1) NFB training and 6 months follow up (T2) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • psychosocial functioning [ Time Frame: T0, T1 and T2 ] [ Designated as safety issue: No ]

Estimated Enrollment: 105
Study Start Date: January 2010
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Neurofeedback
Children in this group receive 30 sessions of neurofeedback
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.
Sham Comparator: Placebo feedback
The children in this group receive 30 sessions of placebo feedback, based on muscular tension.
Other: 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: Siblings
The siblings will be tested 1 time, they will function as a healthy control group.

  Eligibility

Ages Eligible for Study:   8 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00961922

Locations
Netherlands
Academic Medical Centre - UvA
Amsterdam, Noord Holland, Netherlands, 1105AZ
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Dutch Cancer Society
  More Information

No publications provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Martha A. Grootenhuis, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT00961922     History of Changes
Other Study ID Numbers: UVA 2008-4013, MEC 09/137
Study First Received: August 18, 2009
Last Updated: October 3, 2012
Health Authority: Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA):
childhood brain tumour survivors

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 24, 2014