Spinal Cord InjuriesNCT03772548
CNS Changes Following SCI
An observational study of Spinal Cord Injuries, run by University of Zurich at 1 site in Switzerland.
Trial summary
The objective of this study is to better understand the structural and functional changes that the central nervous system (CNS) undergoes following spinal cord injury and how these changes relate to clinical measures. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- MRI
- How many people
- 450 participants
- Where
- 1 siteSwitzerland
- Study dates
- 18 Jul 2018to 30 Jun 2027
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with spinal cord injury and healthy subjects.
Who may be able to join
- Age 18-75
- Traumatic or non-traumatic spinal cord injury (para- and tetraplegia)
- Acute (<4 weeks post SCI) to chronic SCI (> 6 months post SCI)
- Signed informed consent
- Age 18-75
- Signed Informed consent
Who cannot join
- Contraindications to magnetic resonance imaging
- Neurological impairment of body function impairments not induced by spinal cord injury
- BMI > 40
- Pregnancy
- Claustrophobia
- Contraindications to magnetic resonance imaging
Show all 11Show fewer
- Pregnancy
- Neurological illness
- Impairment of body function induced by a spinal cord injury
- Claustrophobia
- BMI > 40
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland1 site, 1 recruiting
- Recruiting
Universitätsklinik Balgrist
Zurich, 8008
Maryam Seif, PD Dr., +41 44 510 72 14, maryam.seif@balgrist.ch
Sanne Kikkert, +41 44 632 32 94, sanne.kikkert@balgrist.ch
About this study
Official title: Functional, Structural, and Metabolic Central Nervous System Changes Following Damage of the Central Nervous System
The objective of this study is to better understand the structural and functional changes that the central nervous system (CNS) undergoes following spinal cord injury and how these changes relate to clinical measures. Both macroscopic and microscopic changes of the brain and the spinal cord will be examined in SCI patients and compared to healthy controls. In terms of structural plasticity, we aim to identify MR biomarkers that allow predicting the course of the patient's neurological status and accurately describe the course of the disease and the recovery. Importantly, we aim to investigate which factors scale the patients' symptoms. In terms of functional plasticity, we will combine fMRI with behavioural testing to understand which clinical and behavioural determinants drive functional hand representations in the primary somatosensory and motor cortices to be maintained and which determinants drive reorganisation of functional representations following sensory input loss. We will further investigate the contribution of brainstem reorganisation to plasticity observed at the cortical level and, by doing so, aim to better understand the mechanistic underpinnings of functional reorganisation.
- Conditions
- Spinal Cord Injuries
- Being tested
- MRI
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
We will examine acute (<4 weeks post SCI) to chronic (>6 months post SCI) patients using functional, structural, and metabolic MRI in both the brain and the spinal cord.
MRIDiagnostic test
We will examine healthy control participants using functional, structural, and metabolic MRI in both the brain and the spinal cord.
| Study group | Role | What they receive |
|---|---|---|
| Patients with spinal cord injury | Not described Receives: Diagnostic Test: MRI | |
| Healthy subjects | Not described Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Conventional magnetic resonance imaging (MRI) parameter
Structural characteristics in the brain and cervical spinal cord are assessed in acute to chronic spinal cord injury (SCI) patients using conventional MRI and compared to healthy controls
Measured: Up to 50 weeks
Secondary outcomes (2)
Magnetic resonance spectroscopy (MRS) parameter
Metabolic parameters are assessed in acute to chronic SCI patients using MRS in the brain and cervical spinal cord and compared to healthy controls
Measured: Up to 50 weeks
Change of functional MRI (fMRI) parameter between 2 to 4 time points
Change of brain activities is assessed between 2 to 4 time points using fMRI during resting-state or a specific task in acute to chronic SCI patients and compared to healthy controls
Measured: Up to 50 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start18 Jul 2018
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies 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
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Patrick Freund, Prof. Dr., Principal investigator, University of Zurich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03772548
- Sponsor's protocol ID
- 2018-00937 - SCI
- Other IDs
- 2018
- Status last verified
- Dec 2025
- First submitted
- 21 Nov 2018
- Last updated
- 15 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kikkert S, Pfyffer D, Verling M, Freund P, Wenderoth N. Finger somatotopy is preserved after tetraplegia but deteriorates over time. Elife. 2021 Oct 19;10:e67713. doi: 10.7554/eLife.67713.
PubMed 34665133
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Functional, Structural, and Metabolic Central Nervous System Changes Following Damage of the Central Nervous System
- ClinicalTrials.gov ID
- NCT03772548
- Acronym / sponsor ID
- 2018-00937 - SCI
- Conditions
- Spinal Cord Injuries
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- 18 Jul 2018 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 11 Dec 2018 (actual)
- 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.
The objective of this study is to better understand the structural and functional changes that the central nervous system (CNS) undergoes following spinal cord injury and how these changes relate to clinical measures. Both macroscopic and microscopic changes of the brain and the spinal cord will be examined in SCI patients and compared to healthy controls. In terms of structural plasticity, we aim to identify MR biomarkers that allow predicting the course of the patient's neurological status and accurately describe the course of the disease and the recovery. Importantly, we aim to investigate which factors scale the patients' symptoms. In terms of functional plasticity, we will combine fMRI with behavioural testing to understand which clinical and behavioural determinants drive functional hand representations in the primary somatosensory and motor cortices to be maintained and which determinants drive reorganisation of functional representations following sensory input loss. We will further investigate the contribution of brainstem reorganisation to plasticity observed at the cortical level and, by doing so, aim to better understand the mechanistic underpinnings of functional reorganisation.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with spinal cord injury | – | Diagnostic Test: MRI |
| Healthy subjects | – | Diagnostic Test: MRI |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with spinal cord injury and healthy subjects.
Key inclusion criteria (6 listed)
- Age 18-75
- Traumatic or non-traumatic spinal cord injury (para- and tetraplegia)
- Acute (<4 weeks post SCI) to chronic SCI (> 6 months post SCI)
- Signed informed consent
- Age 18-75
Key exclusion criteria (11 listed)
- Contraindications to magnetic resonance imaging
- Neurological impairment of body function impairments not induced by spinal cord injury
- BMI > 40
- Pregnancy
- Claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIWe will examine acute (<4 weeks post SCI) to chronic (>6 months post SCI) patients using functional, structural, and metabolic MRI in both the brain and the spinal cord. | Diagnostic test | Patients with spinal cord injury |
| MRIWe will examine healthy control participants using functional, structural, and metabolic MRI in both the brain and the spinal cord. | Diagnostic test | Healthy subjects |
Primary outcome
Conventional magnetic resonance imaging (MRI) parameter
Time frame: Up to 50 weeks
Structural characteristics in the brain and cervical spinal cord are assessed in acute to chronic spinal cord injury (SCI) patients using conventional MRI and compared to healthy controls
2 secondary outcomes
Magnetic resonance spectroscopy (MRS) parameter
Time frame: Up to 50 weeks
Change of functional MRI (fMRI) parameter between 2 to 4 time points
Time frame: Up to 50 weeks
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 15 Dec 2025.
- Derived from this study: PubMed 34665133Kikkert S, Pfyffer D, Verling M, Freund P, Wenderoth N. Finger somatotopy is preserved after tetraplegia but deteriorates over time. Elife. 2021 Oct 19;10:e67713. doi: 10.7554/eLife.67713.
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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, Prof. Dr. principal investigator
University of Zurich
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 Cord Injuries, 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 6 inclusion and 11 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 15 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 Maryam Seif, PD Dr. (+41 44 510 72 14, maryam.seif@balgrist.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Conventional magnetic resonance imaging (MRI) parameter (time frame: Up to 50 weeks). 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 NCT03772548, which also lists 1 linked publication.
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 15 Dec 2025.