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Completed

NCT Number: NCT02149511

Longitudinal Morphometric Changes Following SCI

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Zurich

Zurich, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Cord and brain volume (mm^3) changes

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • Foundation Wings For Life

Registry information

Important dates

Study start
2010
Primary completion
2019
Study completion
2019
First posted
May 29, 2014
Registry last updated
Sep 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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