CClinicalTrials.gg
CompletedNCT04302857Updated Jun 10, 2022

Tractography Pilot Study Leipzig

An observational study in Intracranial Neoplasm, sponsored by Tim Wende. Completed at 1 site in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-06-10.

Sponsored by Tim Wende · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
20
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Intracranial Neoplasm

Browse trials for

03

In context

Brain Neoplasms

1,960 studies on the registry are indexed under Brain Neoplasms; 516 are open to participants now.

This study's enrollment of 20 is below the median of 100 across 380 observational studies indexed under Brain Neoplasms.

Browse Brain Neoplasms studies →

Lead sponsor

This is the only study on the registry with Tim Wende as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Standard cohort of neurosurgical patients

Inclusion criteria

  • intracranial lesion
  • elective neurosurgical procedure

Exclusion criteria

Exclusion Criteria:

  • MRI not applicable
  • cerebral ischemia during study period
  • pregnancy during study period
  • encephalitis during study period
  • spontaneous intracerebral hemorrhage during study period
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
20 participants (actual)
Patient registry
No

Interventions

  • Otherroutine MRI

    MRI with routine DTI sequence

06

What researchers measure

Primary outcomes

  1. Neurological Performance

    Neurological Performance Score (NPS)

    Time frame: three months

07

Study locations

1 site
  • Leipzig University Hospital, Department of Neurosurgery
    Leipzig, Sachsen 04103, Germany
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 10, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04302857
Lead sponsor
Tim Wende
Responsible party
Tim Wende (MD, University of Leipzig) — Sponsor-investigator
First posted
Mar 10, 2020
Start date
Jan 1, 2020
Primary completion
Dec 31, 2021
Completion
Dec 31, 2021
Last update
Jun 10, 2022

Study contacts

Jürgen Meixensberger, MD
study chair · University of Leipzig

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion