search
Back to results

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

Primary Purpose

Brain Tumors

Status
Unknown status
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Neurofeedback
Placebo feedback
Sponsored by
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Brain Tumors focused on measuring childhood brain tumour survivors

Eligibility Criteria

8 Years - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • Academic Medical Centre - UvA

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Sham Comparator

No Intervention

Arm Label

Neurofeedback

Placebo feedback

Siblings

Arm Description

Children in this group receive 30 sessions of neurofeedback

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

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

Outcomes

Primary Outcome Measures

Neurocognitive functioning

Secondary Outcome Measures

psychosocial functioning

Full Information

First Posted
August 18, 2009
Last Updated
October 3, 2012
Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators
Dutch Cancer Society
search

1. Study Identification

Unique Protocol Identification Number
NCT00961922
Brief Title
Pediatric Research on Improving Speed, Memory and Attention
Acronym
PRISMA
Official Title
The Efficacy of Neurofeedback to Improve Processing Speed, Attention and Memory in Childhood Brain Tumour Survivors: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Unknown status
Study Start Date
January 2010 (undefined)
Primary Completion Date
October 2013 (Anticipated)
Study Completion Date
July 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Collaborators
Dutch Cancer Society

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumors
Keywords
childhood brain tumour survivors

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
105 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Neurofeedback
Arm Type
Experimental
Arm Description
Children in this group receive 30 sessions of neurofeedback
Arm Title
Placebo feedback
Arm Type
Sham Comparator
Arm Description
The children in this group receive 30 sessions of placebo feedback, based on muscular tension.
Arm Title
Siblings
Arm Type
No Intervention
Arm Description
The siblings will be tested 1 time, they will function as a healthy control group.
Intervention Type
Other
Intervention Name(s)
Neurofeedback
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo feedback
Intervention Description
Feedback based on a random signal generator and muscular tension instead of brain activity. 30 sessions at home, twice a week, total 15 weeks.
Primary Outcome Measure Information:
Title
Neurocognitive functioning
Time Frame
Before (T0) and after (T1) NFB training and 6 months follow up (T2)
Secondary Outcome Measure Information:
Title
psychosocial functioning
Time Frame
T0, T1 and T2

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Academic Medical Centre - UvA
City
Amsterdam
State/Province
Noord Holland
ZIP/Postal Code
1105AZ
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
23217162
Citation
de Ruiter MA, Schouten-Van Meeteren AY, van Mourik R, Janssen TW, Greidanus JE, Oosterlaan J, Grootenhuis MA. Neurofeedback to improve neurocognitive functioning of children treated for a brain tumor: design of a randomized controlled double-blind trial. BMC Cancer. 2012 Dec 6;12:581. doi: 10.1186/1471-2407-12-581.
Results Reference
derived

Learn more about this trial

Pediatric Research on Improving Speed, Memory and Attention

We'll reach out to this number within 24 hrs