CNS Changes Following SCI
Functional, Structural, and Metabolic Central Nervous System Changes Following Damage of the Central Nervous System
1 other identifier
observational
450
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2018
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 18, 2018
CompletedFirst Submitted
Initial submission to the registry
November 21, 2018
CompletedFirst Posted
Study publicly available on registry
December 11, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
December 15, 2025
December 1, 2025
9 years
November 21, 2018
December 8, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Up to 50 weeks
Secondary Outcomes (2)
Magnetic resonance spectroscopy (MRS) parameter
Up to 50 weeks
Change of functional MRI (fMRI) parameter between 2 to 4 time points
Up to 50 weeks
Study Arms (2)
Patients with spinal cord injury
Healthy subjects
Interventions
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.
Eligibility Criteria
Patients with spinal cord injury and healthy subjects.
You may qualify if:
- 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
You may not qualify if:
- Contraindications to magnetic resonance imaging
- Neurological impairment of body function impairments not induced by spinal cord injury
- BMI \> 40
- Pregnancy
- Claustrophobia
- Age 18-75
- Signed Informed consent
- Contraindications to magnetic resonance imaging
- Pregnancy
- Neurological illness
- Impairment of body function induced by a spinal cord injury
- Claustrophobia
- BMI \> 40
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Universitätsklinik Balgrist
Zurich, 8008, Switzerland
Related Publications (1)
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.
PMID: 34665133DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Patrick Freund, Prof. Dr.
University of Zurich
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 21, 2018
First Posted
December 11, 2018
Study Start
July 18, 2018
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
December 15, 2025
Record last verified: 2025-12