Pediatric Research on Improving Speed, Memory and Attention | NCT00961922

Studies
Pediatric Research on Improving Speed, Memory and Attention

NCT00961922

Sponsor

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

Status

Unknown status

Last Update Posted

Oct 4, 2012Estimated

Enrollment

105Estimated

Phase

Not Applicable

Conditions

Brain Tumors

Interventions

Neurofeedback
Placebo feedback

Countries

Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
MEC 09/137

Status Module

Record Verification Date

Oct 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2010

Primary Completion Date

Oct 2013Estimated

Completion Date

Jul 2014Estimated

First Submitted Date

Aug 18, 2009

First Submission Date that Met QC Criteria

Aug 18, 2009

First Posted Date

Aug 19, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 3, 2012

Last Update Posted Date

Oct 4, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Martha A. Grootenhuis, PhD, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Principal Investigator

Lead Sponsor

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

Collaborators

Name	Class
Dutch Cancer Society	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

105Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Neurofeedback	Experimental	Children in this group receive 30 sessions of neurofeedback	Other: Neurofeedback
Placebo feedback	Sham Comparator	The children in this group receive 30 sessions of placebo feedback, based on muscular tension.	Other: Placebo feedback
Siblings	No Intervention	The siblings will be tested 1 time, they will function as a healthy control group.

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Neurofeedback	Other	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.	Neurofeedback

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Neurocognitive functioning		Before (T0) and after (T1) NFB training and 6 months follow up (T2)

Secondary Outcomes

Measure	Description	Time Frame
psychosocial functioning		T0, T1 and T2

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

8 Years

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Academic Medical Centre - UvA		Amsterdam	North Holland	1105AZ	Netherlands

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
23217162	Derived	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.

Type	Date	Date Unknown
Release	Feb 21, 2017
Reset	Apr 5, 2017

ID	Term
D016543	Central Nervous System Neoplasms
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D001676	Biofeedback, Psychology
D026441	Mind-Body Therapies
D000529	Complementary Therapies
D013812	Therapeutics