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Tractography Pilot Study Leipzig

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04302857
Recruitment Status : Recruiting
First Posted : March 10, 2020
Last Update Posted : March 10, 2020
Information provided by (Responsible Party):
Tim Wende, University of Leipzig

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.

Condition or disease Intervention/treatment
Intracranial Neoplasm Other: routine MRI

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pilot Study for Establishing Perioperative Tractography at Leipzig University Neurosurgery
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : June 30, 2022

Intervention Details:
  • Other: routine MRI
    MRI with routine DTI sequence

Primary Outcome Measures :
  1. Neurological Performance [ Time Frame: three months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Standard cohort of neurosurgical patients

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04302857

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Contact: Tim Wende, MD 00493419717956
Contact: Jürgen Meixensberger, MD 00493419717599

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Leipzig University Hospital, Department of Neurosurgery Recruiting
Leipzig, Sachsen, Germany, 04103
Contact: Tim Wende, MD         
Sponsors and Collaborators
Tim Wende
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Responsible Party: Tim Wende, MD, University of Leipzig Identifier: NCT04302857    
Other Study ID Numbers: 322/19-ek
First Posted: March 10, 2020    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases