Longitudinal Morphometric Changes Following SCI

Spinal Cord Injury Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02149511
• Other study ID #: KEK-ZH 2010-0271/PB_2016-00230
• Status: Completed
• Start date: September 2010
• Est. completion date: September 2019

Study information

• Verified date: August 2020
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In patients with chronic spinal cord injury, imaging of the spinal cord and brain above the level of the lesion provides evidence of neural degeneration; however, the spatial and temporal patterns of progression and their relation to clinical outcomes are uncertain. New interventions targeting acute spinal cord injury have entered clinical trials but neuroimaging outcomes as responsive markers of treatment have yet to be established. We aim to use MRI to assess neuronal degeneration above and below the level of the lesion after acute spinal cord injury. In our prospective longitudinal study, we enroll patients with acute traumatic spinal cord injury and healthy controls. We assess patients clinically and by MRI at baseline, 2 months, 6 months, 12 months, and if possible 24 months and 60 months follow-up, and controls by MRI at the same timepoints. We assess cervical atrophy in white and gray matter and use cross-sectional spinal cord area measurements to assess atrophy at cervical level (C2/C3) and in the lumbar enlargement. We use myelinsensitive magnetisation transfer (MT) and longitudinal relaxation rate (R1) maps in the brain to assess microstructural changes associated with myelin. We also use diffusion tensor imaging acquired in the spinal cord at C2/C3 and in the lumbar enlargement to identify axonal loss and demyelination in the spinal white matter. Finally, we assess associations between MRI parameters and clinical improvement.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: September 2019
• Est. primary completion date: September 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

SCI patients:

• acute injury to the spinal cord

• no medical or mental illness

• written informed consent

• over the age of 18 years

Control subjects:

• over the age of 18 years

• written informed consent

Exclusion Criteria:

SCI patients:

• head or brain lesion associated with the trauma leading to the injury

• epileptic seizures

• MRI contraindications

• pregnant women or lactating women

Control subjects:

• pregnant women or lactating women

• MRI contraindications

• neurological or psychiatric illness

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Spinal Cord Injury

Locations

Country	Name	City	State
Switzerland	University of Zurich	Zurich

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	Foundation Wings For Life

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cord and brain volume (mm^3) changes		Patients will be recruited within the first months of injury and scanned 6 times during the first 5 years post injury. Healthy controls will follow the same time line.