Brain TumorsPRISMANCT00961922
Pediatric Research on Improving Speed, Memory and Attention
A study testing Neurofeedback in people with Brain Tumors, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 8 to 18 years
- Conditions the study is for
- Brain Tumors
- What is being tested?
- Neurofeedback
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 105 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2010to Jul 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Premorbid AD/HD
- Mental or physical condition that make the neuropsychological assessment impossible to finish
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Academic Medical Centre - UvA
Amsterdam, North Holland, 1105AZ
About this study
Official title: The Efficacy of Neurofeedback to Improve Processing Speed, Attention and Memory in Childhood Brain Tumour Survivors: a Randomized Controlled Trial
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).
Read more
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.
- Conditions
- Brain Tumors
- Being tested
- Neurofeedback, Placebo feedback
- Keywords
- childhood brain tumour survivors
- Medical subject headings
- Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeurofeedbackOther
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 feedbackOther
Feedback based on a random signal generator and muscular tension instead of brain activity. 30 sessions at home, twice a week, total 15 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Neurofeedback | Experimental | Children in this group receive 30 sessions of neurofeedback Receives: Other: Neurofeedback |
| Placebo feedback | Sham comparator | The children in this group receive 30 sessions of placebo feedback, based on muscular tension. Receives: Other: Placebo feedback |
| Siblings | No intervention | The siblings will be tested 1 time, they will function as a healthy control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurocognitive functioning
Measured: Before (T0) and after (T1) NFB training and 6 months follow up (T2)
Secondary outcomes (1)
psychosocial functioning
Measured: T0, T1 and T2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2009 (estimated)
- Study startJan 2010
- Primary completionOct 2013 (estimated)
- Study completionJul 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Brain TumorsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 105 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Collaborators
- Dutch Cancer Society
- Responsible party
- Principal investigator, Martha A. Grootenhuis, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00961922
- Sponsor's protocol ID
- UVA 2008-4013
- Other IDs
- MEC 09/137
- Acronym
- PRISMA
- Status last verified
- Oct 2012
- First submitted
- 18 Aug 2009
- Last updated
- 4 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23217162
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Neurofeedback to Improve Processing Speed, Attention and Memory in Childhood Brain Tumour Survivors: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00961922
- Acronym / sponsor ID
- PRISMA / UVA 2008-4013
- Conditions
- Brain Tumors
- Keywords
- childhood brain tumour survivors
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 105 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Collaborators
- Dutch Cancer Society
- Study start
- Jan 2010
- Primary completion
- Oct 2013 (estimated)
- Study completion
- Jul 2014 (estimated)
- First posted
- 19 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Neurofeedback | Experimental | Other: NeurofeedbackChildren in this group receive 30 sessions of neurofeedback |
| Placebo feedback | Sham comparator | Other: Placebo feedbackThe children in this group receive 30 sessions of placebo feedback, based on muscular tension. |
| Siblings | No intervention | –The siblings will be tested 1 time, they will function as a healthy control group. |
Who may qualify
- Ages
- 8 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Premorbid AD/HD
- Mental or physical condition that make the neuropsychological assessment impossible to finish
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neurofeedback30 sessions of neurofeedback will be given twice a week at the child's home. It will take about 15 weeks to complete the training. | Other | Neurofeedback |
| Placebo feedbackFeedback based on a random signal generator and muscular tension instead of brain activity. 30 sessions at home, twice a week, total 15 weeks. | Other | Placebo feedback |
Primary outcome
Neurocognitive functioning
Time frame: Before (T0) and after (T1) NFB training and 6 months follow up (T2)
1 secondary outcome
psychosocial functioning
Time frame: T0, T1 and T2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2012.
- Derived from this study: PubMed 23217162de 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neurofeedback in people with Brain Tumors, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurocognitive functioning (time frame: Before (T0) and after (T1) NFB training and 6 months follow up (T2)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00961922, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2012.