Cerebellum - Cognitive Outcome and Functional Connectivity

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2012 by Medical University of Vienna
Sponsor:
Information provided by (Responsible Party):
Christian Dorfer, Medical University of Vienna
ClinicalTrials.gov Identifier:
NCT01730274
First received: November 15, 2012
Last updated: November 20, 2012
Last verified: November 2012
  Purpose

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
Childhood Cerebellar Tumor

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Cerebellar Tumors of Childhood - Impact on Cognition and Functional Connectivity

Resource links provided by NLM:


Further study details as provided by Medical University of Vienna:

Primary Outcome Measures:
  • neuropsychological assessment [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: January 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
patients
children operated on a cerebellar tumor
healthy subjects
healthy volunteers

  Eligibility

Ages Eligible for Study:   15 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

young adolescent operated on a cerebellar tumor as a child

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01730274

Contacts
Contact: Christian Dorfer, MD 0043140400 ext 4560 christian.dorfer@meduniwien.ac.at

Locations
Austria
MUV, Department of Neurosurgery Not yet recruiting
Vienna, Austria, 1090
Contact: Christian Dorfer, MD       christian.dorfer@meduniwien.ac.at   
Sponsors and Collaborators
Medical University of Vienna
Investigators
Principal Investigator: Christian Dorfer, MD MUV, Department of Neurosurgery
  More Information

No publications provided

Responsible Party: Christian Dorfer, Dr.med.univ., Medical University of Vienna
ClinicalTrials.gov Identifier: NCT01730274     History of Changes
Other Study ID Numbers: cerebellum 1.1, KLI 252
Study First Received: November 15, 2012
Last Updated: November 20, 2012
Health Authority: Austria: Agency for Health and Food Safety

Additional relevant MeSH terms:
Cerebellar Neoplasms
Infratentorial Neoplasms
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Cerebellar Diseases

ClinicalTrials.gov processed this record on September 30, 2014