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Completed

NCT Number: NCT04302857

Tractography Pilot Study Leipzig

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.

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Key information

Conditions

Intracranial Neoplasm Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Leipzig University Hospital, Department of Neurosurgery

Leipzig, Saxony, 04103, Germany

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

routine MRI

Other

MRI with routine DTI sequence

Primary outcomes

  1. Neurological Performance

    Time frame: three months

    Neurological Performance Score (NPS)

Sponsors and collaborators

Lead sponsor

Tim Wende

Other

Registry information

Official study title

Pilot Study for Establishing Perioperative Tractography at Leipzig University Neurosurgery

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 10, 2020
Registry last updated
Jun 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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