Spinal InjuryNCT02170155
MRI-changes in Morphometry and Cerebro Spinale Fluid (CSF) Flow in Spinal Cord Disorders
An observational study of Spinal Injury, run by University of Zurich at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Injury
- How many people
- 350 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2012to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects with spinal cord disorder and CSM
Who may be able to join
- Cervical injury
- Informed consent
- Age 18-80
- CSM
Who cannot join
- No other neurologic disorder and psychiatric disorder
- Seizure
- MRI incompatibility
- Pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Patrick Freund, PhD contact
Switzerland1 site, 1 recruiting
- Recruiting
University of Zurich, Balgrist University Hospital
Zurich, Canton of Zurich, 8008
Armin Curt, MD, +41 44 386 39 01, armin.curt@balgrist.ch
About this study
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
- Medical subject headings
- Spinal Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with CSM | Not described | |
| Patients with spinal injury (SCI) | Not described | |
| Healthy controls | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: Perioperative for 24hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2014 (estimated)
- Study startDec 2012
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Spinal InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation Wings For Life, Balgrist Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02170155
- Sponsor's protocol ID
- KEK-ZH-2012-0343/PB_2016-00623
- Status last verified
- Dec 2025
- First submitted
- 5 Jun 2014
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 38978814Kheram 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.
PubMed 37079108Zipser 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.
PubMed 32958488
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MRI-changes in Morphometry and Cerebro Spinale Fluid (CSF) Flow in Spinal Cord Disorders
- ClinicalTrials.gov ID
- NCT02170155
- Acronym / sponsor ID
- KEK-ZH-2012-0343/PB_2016-00623
- Conditions
- Spinal Injury
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Foundation Wings For Life, Balgrist Foundation
- Study start
- Dec 2012
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 23 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients with CSM | – | – |
| Patients with spinal injury (SCI) | – | – |
| Healthy controls | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with spinal cord disorder and CSM
Key inclusion criteria (4 listed)
- Cervical injury
- Informed consent
- Age 18-80
- CSM
Key exclusion criteria (4 listed)
- No other neurologic disorder and psychiatric disorder
- Seizure
- MRI incompatibility
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Assessment of CSF pressure dynamics in the perioperative setting
Time frame: Perioperative for 24hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Derived from this study: PubMed 38978814Pfender 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.
- Derived from this study: PubMed 37079108Kheram 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.
- Derived from this study: PubMed 32958488Zipser 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Patrick Freund, PhD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Injury, run by University of Zurich at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patrick Freund, PhD (patrick.freund@balgrist.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02170155, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.