Longitudinal Morphometric Changes Following SCI

NCT ID: NCT02149511

Last Updated: 2020-09-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 94 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2019-09-30

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

SCI subjects

No interventions assigned to this group

healthy control subjects

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Foundation Wings For Life

OTHER

Sponsor Role: collaborator

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University of Zurich

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

KEK-ZH 2010-0271/PB_2016-00230

Identifier Type: -

Identifier Source: org_study_id