Longitudinal Morphometric Changes Following SCI | NCT02149511

Studies
Longitudinal Morphometric Changes Following SCI

NCT02149511

Sponsor

University of Zurich

Status

Completed

Last Update Posted

Sep 17, 2020Actual

Enrollment

94Actual

Phase

Not provided

Conditions

Spinal Cord Injury

Interventions

Not provided

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Sep 2019Actual

Completion Date

Sep 2019Actual

First Submitted Date

May 16, 2014

First Submission Date that Met QC Criteria

May 26, 2014

First Posted Date

May 29, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 15, 2020

Last Update Posted Date

Sep 17, 2020Actual

Name	Class
Foundation Wings For Life	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

94Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Acute and chronic patients with spinal cord involvement

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Zurich		Zurich			Switzerland

Condition Browse Module

MeSH Terms

ID	Term
D013119	Spinal Cord Injuries

Ancestor Terms

ID	Term
D013118	Spinal Cord Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D020196	Trauma, Nervous System

Browse Leaves

Not provided

Browse Branches

Not provided

Label	Type	Description	Intervention Names
SCI subjects
healthy control subjects