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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01730274
Other study ID # cerebellum 1.1
Secondary ID KLI 252
Status Completed
Phase
First received
Last updated
Start date January 2013
Est. completion date February 2015

Study information

Verified date February 2021
Source Medical University of Vienna
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date February 2015
Est. primary completion date September 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 15 Years to 30 Years
Eligibility Inclusion Criteria: - • 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 Exclusion Criteria: - • Patients with Neurofibromatosis 1 - Severe visual or auditory impairment - Cerebrospinal fluid shunt device - Prior radiotherapy or chemotherapy - Contraindications to MRI

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Austria MUV, Department of Neurosurgery Vienna

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Vienna

Country where clinical trial is conducted

Austria, 

Outcome

Type Measure Description Time frame Safety issue
Primary neuropsychological assessment up to 24 months