Longitudinal Morphometric Changes Following SCI

NCT02149511 | Completed DMC

• 1 other identifier: KEK-ZH 2010-0271/PB_2016-00230
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Cord Injury

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (2)

SCI subjects

healthy control subjects

Eligibility Criteria

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

Study Population

Acute and chronic patients with spinal cord involvement

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

University of Zurich

Zurich, Switzerland

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

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

Study Record Dates

• First Submitted: May 16, 2014
• First Posted: May 29, 2014
• Study Start: September 1, 2010
• Primary Completion: September 1, 2019
• Study Completion: September 1, 2019
• Last Updated: September 17, 2020

Record last verified: 2020-08

Locations

CH (1)