Childhood Cerebellar TumorNCT01730274
Cerebellum - Cognitive Outcome and Functional Connectivity
An observational study of Childhood Cerebellar Tumor, run by Medical University of Vienna at 1 site in Austria.
Trial summary
Aim: To investigate the effect of cerebellar tumor surgery on the resting state functional connectivity level in higher order cognition networks known to interact with the cerebellum. Read more about this study
- Who is it for?
- Ages 15 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Childhood Cerebellar Tumor
- How many people
- 31 participants
- Where
- 1 siteAustria
- Study dates
- Jan 2013to Feb 2015
- Phase
- Observational
- 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 15 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: young adolescent operated on a cerebellar tumor as a child
Who may be able to join
- • Male or female patients aged > 15 yrs
- Age at surgery between 1 yrs - 12 yrs
- Compliance (the patients have to be able to lay motionless in a 3 Tesla MR scanner and to cooperate with the examiner during the examination)
- Signed informed consent from the patient and/or the parents
Who cannot join
- • Patients with Neurofibromatosis 1
- Severe visual or auditory impairment
- Cerebrospinal fluid shunt device
- Prior radiotherapy or chemotherapy
- Contraindications to MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cerebellar Tumors of Childhood - Impact on Cognition and Functional Connectivity
Aim: To investigate the effect of cerebellar tumor surgery on the resting state functional connectivity level in higher order cognition networks known to interact with the cerebellum. Furthermore, to correlate the connectivity level of these networks with the neuropsychological performance and functional outcome of the patients.
The investigator's hypothesis is that the functional connectivity of various cognition networks in the cerebrum as assessed by resting-state functional magnetic resonance imaging can be impaired after cerebellar tumor surgery and can be correlated with the neuropsychological performance. The effect of surgery on the cognition networks and the neuropsychological performance is dependent on the tumor location within the cerebellum. Such a correlation seems feasible as functional connectivity analysis could be correlated with the neuropsychological impairment in various neuropsychiatric disorders. Furthermore, investigators were able to depict the maturation of the functional connectivity networks in parallel to the neurocognitive development in childhood
- Conditions
- Childhood Cerebellar Tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| patients | children operated on a cerebellar tumor | |
| healthy subjects | healthy volunteers |
What is being measured
The primary outcome is the main question the study is designed to answer.
neuropsychological assessment
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2012 (estimated)
- Study startJan 2013
- Primary completionSep 2014
- Study completionFeb 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood Cerebellar TumorStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Dorfer, Medical University of Vienna
- Investigators
- Christian Dorfer, MD, Principal investigator, MUV, Department of Neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01730274
- Sponsor's protocol ID
- cerebellum 1.1
- Other IDs
- KLI 252
- Status last verified
- Feb 2021
- First submitted
- 15 Nov 2012
- Last updated
- 24 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebellar Tumors of Childhood - Impact on Cognition and Functional Connectivity
- ClinicalTrials.gov ID
- NCT01730274
- Acronym / sponsor ID
- cerebellum 1.1
- Conditions
- Childhood Cerebellar Tumor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Sep 2014 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 21 Nov 2012 (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.
Aim: To investigate the effect of cerebellar tumor surgery on the resting state functional connectivity level in higher order cognition networks known to interact with the cerebellum. Furthermore, to correlate the connectivity level of these networks with the neuropsychological performance and functional outcome of the patients.
The investigator's hypothesis is that the functional connectivity of various cognition networks in the cerebrum as assessed by resting-state functional magnetic resonance imaging can be impaired after cerebellar tumor surgery and can be correlated with the neuropsychological performance. The effect of surgery on the cognition networks and the neuropsychological performance is dependent on the tumor location within the cerebellum. Such a correlation seems feasible as functional connectivity analysis could be correlated with the neuropsychological impairment in various neuropsychiatric disorders. Furthermore, investigators were able to depict the maturation of the functional connectivity networks in parallel to the neurocognitive development in childhood
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients | – | –children operated on a cerebellar tumor |
| healthy subjects | – | –healthy volunteers |
Who may qualify
- Ages
- 15 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- young adolescent operated on a cerebellar tumor as a child
Key inclusion criteria (4 listed)
- • Male or female patients aged > 15 yrs
Key exclusion criteria (5 listed)
- • Patients with Neurofibromatosis 1
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
neuropsychological assessment
Time frame: up to 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2021.
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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.
Christian Dorfer, MD principal investigator
MUV, Department of Neurosurgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Childhood Cerebellar Tumor, run by Medical University of Vienna at 1 site in Austria.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 24 Feb 2021. 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 Austria. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
neuropsychological assessment (time frame: up to 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2021.