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

NCT02170155 | Recruiting DMC

• 1 other identifier: KEK-ZH-2012-0343/PB_2016-00623
• Study Type: observational
• Target: 350
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Injury

Outcome Measures

Primary Outcomes (2)

• 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

• Assessment of CSF pressure dynamics in the perioperative setting

  Perioperative for 24hours

Study Arms (3)

Patients with CSM

Patients with spinal injury (SCI)

Healthy controls

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects with spinal cord disorder and CSM

You may qualify if:

• Cervical injury
• Informed consent
• Age 18-80
• CSM

You may not qualify if:

• No other neurologic disorder and psychiatric disorder
• Seizure
• MRI incompatibility
• Pregnancy

Sponsors & Collaborators

• Foundation Wings For Life: collaborator
• Balgrist Foundation: collaborator
• University of Zurich: lead

Study Sites (1)

University of Zurich, Balgrist University Hospital

Zurich, Canton of Zurich, 8008, Switzerland

RECRUITING

Related Publications (3)

• Pfender N, Jutzeler CR, Hubli M, Scheuren PS, Pfyffer D, Zipser CM, Rosner J, Friedl S, Sutter R, Spirig JM, Betz M, Schubert M, Seif M, Freund P, Farshad M, Curt A, Hupp M. Potential thresholds of critically increased cardiac-related spinal cord motion in degenerative cervical myelopathy. Front Neurol. 2024 Jun 24;15:1411182. doi: 10.3389/fneur.2024.1411182. eCollection 2024.

  PMID: 38978814 DERIVED

• Kheram N, Boraschi A, Pfender N, Spiegelberg A, Kurtcuoglu V, Curt A, Schubert M, Zipser CM. Queckenstedt's test repurposed for the quantitative assessment of the cerebrospinal fluid pulsatility curve. Acta Neurochir (Wien). 2023 Jun;165(6):1533-1543. doi: 10.1007/s00701-023-05583-w. Epub 2023 Apr 20.

  PMID: 37079108 DERIVED

• Zipser CM, Pfender N, Spirig JM, Betz M, Aguirre J, Hupp M, Farshad M, Curt A, Schubert M. Study protocol for an observational study of cerebrospinal fluid pressure in patients with degenerative cervical myelopathy undergoing surgical deCOMPression of the spinal CORD: the COMP-CORD study. BMJ Open. 2020 Sep 21;10(9):e037332. doi: 10.1136/bmjopen-2020-037332.

  PMID: 32958488 DERIVED

MeSH Terms

Conditions

Spinal Injuries

Condition Hierarchy (Ancestors)

Back Injuries; Wounds and Injuries

Central Study Contacts

Patrick Freund, PhD

CONTACT

patrick.freund@balgrist.ch

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2014
• First Posted: June 23, 2014
• Study Start: December 1, 2012
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: December 22, 2025

Record last verified: 2025-12

Locations

CH (1)