- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02170155
MRI-changes in Morphometry and Cerebro Spinale Fluid (CSF) Flow in Spinal Cord Disorders
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Patrick Freund, PhD
- Email: patrick.freund@balgrist.ch
Study Locations
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Zurich, Switzerland, 8008
- Recruiting
- University of Zurich, Balgrist University Hospital
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Contact:
- Armin Curt, MD
- Phone Number: +41 44 386 39 01
- Email: armin.curt@balgrist.ch
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Cervical injury
- Informed consent
- Age 18-80
- CSM
Exclusion Criteria:
- No other neurologic disorder and psychiatric disorder
- Seizure
- MRI incompatibility
- Pregnancy
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Healthy controls
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Patients with CSM
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Patients with spinal injury (SCI)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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).
Time Frame: 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
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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
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Assessment of CSF pressure dynamics in the perioperative setting
Time Frame: Perioperative for 24hours
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Perioperative for 24hours
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KEK-ZH-2012-0343/PB_2016-00623
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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