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

Spinal Injury Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02170155
• Other study ID #: KEK-ZH-2012-0343/PB_2016-00623
• Status: Recruiting
• Start date: December 2012
• Est. completion date: December 2026

Study information

• Verified date: August 2023
• Source: University of Zurich
• Contact: Patrick Freund, PhD
• Email: patrick.freund[@]balgrist.ch
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Cervical injury

• Informed consent

• Age 18-80

• CSM

Exclusion Criteria:

• No other neurologic disorder and psychiatric disorder

• Seizure

• MRI incompatibility

• Pregnancy

Related Conditions & MeSH terms

• Spinal Injuries
• Spinal Injury

Locations

Country	Name	City	State
Switzerland	University of Zurich, Balgrist University Hospital	Zurich

Sponsors (3)

Lead Sponsor	Collaborator
University of Zurich	Balgrist Foundation, Foundation Wings For Life

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Assessment of CSF pressure dynamics in the perioperative setting		Perioperative for 24hours