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Clinical Trials/NCT04302857
NCT04302857
Completed
Not Applicable

Pilot Study for Establishing Perioperative Tractography at Leipzig University Neurosurgery

Tim Wende1 site in 1 country20 target enrollmentJanuary 1, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intracranial Neoplasm
Sponsor
Tim Wende
Enrollment
20
Locations
1
Primary Endpoint
Neurological Performance
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

In this pilot study participants will undergo routine magnetic resonance imaging and routine neurosurgical care. By prospectively collecting data from both MRI and patient records we want to investigate biomarkers derived from tractography and diffusion tensor imaging to predict rehabilitation potential.

Detailed Description

Patients will undergo MRI before and after surgery with DTI. With CSD-tractography, fiber bundles and their volumes will be identified. By measuring fractional anisotropy (FA) within these volumes, a correlation with clinical outcome and recovery will be tested. Also, FA frequency distributions will be used to describe white matter integrity and to thereby improve future tractography algorithms. Fiber bundles of interest will be the arcuate fascicle (AF), the corticospinal tract (CST), frontal aslant tract (FAT), the inferior fronto-occipital fascicle (IFOF), the inferior longitudinal fascicle (ILF) and the uncinate fascicle (UF).

Registry
clinicaltrials.gov
Start Date
January 1, 2020
End Date
December 31, 2021
Last Updated
3 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Tim Wende
Responsible Party
Sponsor Investigator
Principal Investigator

Tim Wende

MD

University of Leipzig

Eligibility Criteria

Inclusion Criteria

  • intracranial lesion
  • elective neurosurgical procedure

Exclusion Criteria

  • MRI not applicable
  • cerebral ischemia during study period
  • pregnancy during study period
  • encephalitis during study period
  • spontaneous intracerebral hemorrhage during study period

Outcomes

Primary Outcomes

Neurological Performance

Time Frame: three months

Neurological Performance Score (NPS)

Study Sites (1)

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