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MRI-changes in Morphometry and Cerebro Spinale Fluid (CSF) Flow in Spinal Cord Disorders

Sponsor
University of Zurich (Other)
Overall Status
Recruiting
CT.gov ID
NCT02170155
Collaborator
Foundation Wings For Life (Other), Balgrist Foundation (Other)
350
Enrollment
1
Location
168
Duration (Months)
2.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Understanding the onset and progression of spinal cord disorders is an important aim in clinical neurology. An early diagnosis with consequent therapy might prevent the progression of disability. Therefore, we aim to determine structural and dynamic changes in the microstructure of the spinal cord and CSF, and to explore the relationships between the MRI parameters, clinical disability, and electrophysiology.

In some patients that undergo decompressive surgery CSF pressure will be measured invasive perioperative for 24h to find out if functional limitations and structural changes correlate with the spinal pressure and the spinal perfusion when the spinal cord is damaged.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    350 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Study Start Date :
    Dec 1, 2012
    Anticipated Primary Completion Date :
    Dec 1, 2026
    Anticipated Study Completion Date :
    Dec 1, 2026

    Arms and Interventions

    Arm Intervention/Treatment
    Patients with CSM
    Patients with spinal injury (SCI)
    Healthy controls

    Outcome Measures

    Primary Outcome Measures

    1. Morphometric changes and changes in cerebro spinal fluid (CSF) flow and spinal cord movement in patients and control subjects will be correlated to functional deficits and neurophysiological data (regression model analysis). [Each patient will undergo a MRI scan, clinical and electrophysiological examinations at baseline, after 6 months and after 1, 2, 3, 4, and 5 years. Controls will undergo 1 MRI scan and some scan of retest analysis]

    2. Assessment of CSF pressure dynamics in the perioperative setting [Perioperative for 24hours]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • Cervical injury

    • Informed consent

    • Age 18-80

    • CSM

    Exclusion Criteria:

    • No other neurologic disorder and psychiatric disorder

    • Seizure

    • MRI incompatibility

    • Pregnancy

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Zurich, Balgrist University Hospital Zurich Switzerland 8008

    Sponsors and Collaborators

    • University of Zurich
    • Foundation Wings For Life
    • Balgrist Foundation

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Zurich
    ClinicalTrials.gov Identifier:
    NCT02170155
    Other Study ID Numbers:
    • KEK-ZH-2012-0343/PB_2016-00623
    First Posted:
    Jun 23, 2014
    Last Update Posted:
    Aug 16, 2022
    Last Verified:
    Aug 1, 2022
    Additional relevant MeSH terms:
    Spinal Injuries

    Study Results

    No Results Posted as of Aug 16, 2022