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Longitudinal Morphometric Changes Following SCI

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ClinicalTrials.gov Identifier: NCT02149511
Recruitment Status : Recruiting
First Posted : May 29, 2014
Last Update Posted : July 11, 2018
Sponsor:
Collaborator:
Foundation Wings For Life
Information provided by (Responsible Party):
University of Zurich

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 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, and 12 months 24 months and 60 months, and controls by MRI at the same timepoints. We assess atrophy in white and brain matter and we use cross-sectional spinal cord area measurements to assess atrophy at cervical level C2/C3. We use myelin-sensitive magnetisation transfer (MT) and longitudinal relaxation rate (R1) maps to assess microstructural changes associated with myelin. We also assess associations between MRI parameters and clinical improvement.

Condition or disease
Spinal Cord Injury

Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Study Start Date : September 2010
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

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Group/Cohort
SCI subjects
healthy control subjects



Primary Outcome Measures :
  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. ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Acute and chronic patients with spinal cord involvement
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02149511


Contacts
Contact: Patrick Freund, PhD patrick.freund@balgrist.ch
Contact: Maryam Seif maryam.seif@balgrist.ch

Locations
Switzerland
University of Zurich Recruiting
Zurich, Switzerland
Contact: Armin Curt, MD    +41 44 386 39 01    Armin.Curt@balgrist.ch   
Sponsors and Collaborators
University of Zurich
Foundation Wings For Life

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT02149511     History of Changes
Other Study ID Numbers: KEK-ZH 2010-0271/PB_2016-00230
First Posted: May 29, 2014    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: July 2018

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries