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Cerebellum - Cognitive Outcome and Functional Connectivity

Sponsor
Medical University of Vienna (Other)
Overall Status
Completed
CT.gov ID
NCT01730274
Collaborator
(none)
31
Enrollment
1
Location
25
Duration (Months)
1.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    31 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Cerebellar Tumors of Childhood - Impact on Cognition and Functional Connectivity
    Study Start Date :
    Jan 1, 2013
    Actual Primary Completion Date :
    Sep 1, 2014
    Actual Study Completion Date :
    Feb 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    patients

    children operated on a cerebellar tumor
    healthy subjects

    healthy volunteers

    Outcome Measures

    Primary Outcome Measures

    1. neuropsychological assessment [up to 24 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 30 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 MUV, Department of Neurosurgery Vienna Austria 1090

    Sponsors and Collaborators

    • Medical University of Vienna

    Investigators

    • Principal Investigator: Christian Dorfer, MD, MUV, Department of Neurosurgery

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Christian Dorfer, Dr.med.univ., Medical University of Vienna
    ClinicalTrials.gov Identifier:
    NCT01730274
    Other Study ID Numbers:
    • cerebellum 1.1
    • KLI 252
    First Posted:
    Nov 21, 2012
    Last Update Posted:
    Feb 24, 2021
    Last Verified:
    Feb 1, 2021
    Additional relevant MeSH terms:
    Cerebellar Neoplasms

    Study Results

    No Results Posted as of Feb 24, 2021