The Natural History of Traumatic Spinal Cord Injury Using fMRI, MRS and DTI

August 25, 2017 updated by: Lawson Health Research Institute

Mapping the Natural History of Traumatic Spinal Cord Injury in the Sensorimotor Cortex Using Functional Magnetic Resonance Imaging, Magnetic Resonance Spectroscopy and Diffusion Tensor Imaging

Traumatic spinal cord injury is a common injury to the spine and can lead to a clinical syndrome called central cord syndrome (CCS). CCS is an incomplete spinal cord injury where one starts to lose more motor function in the upper rather than lower extremities. It affects a wide range of the population from the young to the old. However, the natural history of CCS is poorly understood.

Research has shown that the injury resulting in CCS might be due to the pinching or compressing of the spinal cord. This creates damage to a part of the spinal cord and creates difficulties in the signal getting through. We believe that we can gain a better understanding of the natural history of incomplete spinal cord injury as well as the recovery process.

It is possible to track many changes in the brain and motor function through a variety of methods. One can track the concentrations of different chemicals (metabolites) by using magnetic resonance spectroscopy (MRS), changes in brain activation by using functional magnetic resonance imaging (fMRI) and thread-like nerve fibers in the spine by using diffusion tensor imaging (DTI). In our study we will be detecting differences in brain metabolism and activation of different parts of the brain during specific movement and in the nerve fibers in the brain.

We hypothesize that there will be decreased levels of N-acetylaspartate (NAA, a putative marker of neuronal function) and decreased levels of glutamate (the primary excitatory neurotransmitter) in the motor cortex in patients with CCS when compared with controls. Over time, we hypothesize that the normalization of metabolite levels will correlate with the extent of neurologic recovery. We also hypothesize a reorganization of brain activation patterns with time such that patients will show increased volumes of activation in the motor cortex with recovery and that this will correlate with the extent of neurologic outcome. Over time, we predict that there will be normalization of the fibre track anatomy that will correlate with neurological recovery.

Study Overview

Status

Completed

Conditions

Central Cord Syndrome

Detailed Description

The long-term goal of this project is to develop predictors of neurological recovery based on brain metabolism, brain activation patterns, and fibre tracks in patients with traumatic CCS. The objective of this preliminary study is to evaluate metabolic changes, brain activation pattern reorganization and altered spinal cord fibre tracks in patients suffering from traumatic CCS to gain a better understanding of the natural history of this condition. Magnetic resonance spectroscopy (MRS), functional magnetic resonance imaging (fMRI), and diffusion tensor imaging (DTI) will be used to investigate the changes in brain metabolite concentrations, cerebral cortical activation, and fibre tract anatomy, respectively, in patients and controls.

Ten patients having traumatic CCS will be recruited from the Clinical Neurological Sciences Department at the London Health Sciences Centre, University Campus. All participants will undergo an fMRI, MRS and DTI scan of the motor cortex to measure the volume of activation, signal intensity and levels of NAA and glutamate. The CCS participants will have three scans, one acutely (up to 48 hours after injury), one subacutely (15 days after injury), and one late (6 months after injury). Healthy volunteers will have two scans six months apart to determine reproducibility.

Clinical changes will be measured using validated disease specific scoring instruments including the Japanese Orthopedic Association scale (JOA), ASIA/ISCOS Impairment Scale, and the Neck Disability Index (NDI). General quality of life will be measured using the 36-item Short-Form Health Survey (SF-36). A blinded investigator will administer these instruments prior to the scan at all time points.

Study Type

Observational

Enrollment (Actual)

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Canada
- Ontario
  - London, Ontario, Canada, N6A-5A5
    - London Health Sciences Center, University Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Ten patients and ten controls will be recruited from the Clinical Neurological Sciences outpatient clinic at the London Health Sciences Centre, University Campus

Description

Inclusion Criteria:

between 30 and 85 years of age
right handed
with normal/corrected hearing and vision
fluent in reading and speaking Canadian or American English
able to follow simple task instructions
able to maintain standardized movements
available to return for the 15 day and 6 month imaging sessions
competent to give consent

Exclusion Criteria:

must not have any other neurological disorder or systemic disease that may affect neurologic function
not have any potential magnetic metal fragments in their body
suffering from claustrophobia
having a pacemaker or other electronic implants
have been or currently is a welder or soldier
have been injured by a metallic object that has not been removed
pregnant or trying to conceive
have cerebral aneurysm clips

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Control Controls (healthy volunteers) will have two scans (fMRI, MRS and DTI) six months apart to determine reproducibility. A blinded investigator will administer JOA, ASIA/ISCOS, NDI and SF-36 prior to the scan at all time points.
CCS Participants CCS participants will have three scans (fMRI, MRS and DTI), one acutely (up to 48 hours after injury), one subacutely (15 days after injury), and one late (6 months after injury). A blinded investigator will administer JOA, ASIA/ISCOS, NDI and SF-36 prior to the scan at all time points.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Measure the volume of activation, signal intensity and levels of NAA and glutamate using fMRI, MRS and DTI. Time Frame: acutely (up to 48 hours after injury), subacutely (15 days after injury), and late (6 months after injury)	acutely (up to 48 hours after injury), subacutely (15 days after injury), and late (6 months after injury)

Secondary Outcome Measures

Outcome Measure	Time Frame
Clinical changes will be measured using validated disease specific scoring instruments including the Japanese Orthopedic Association scale (JOA), ASIA/ISCOS Impairment Scale, and the Neck Disability Index (NDI). Time Frame: Acutely (up to 48 hours after injury), subacutely (15 days after injury), and late (6 months after injury)	Acutely (up to 48 hours after injury), subacutely (15 days after injury), and late (6 months after injury)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Collaborators

The Physicians' Services Incorporated Foundation

Investigators

Principal Investigator: Neil Duggal, M.D., MSc, London Health Research Institute, London Health Sciences Centre

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 18, 2009

Primary Completion (ACTUAL)

January 31, 2010

Study Completion (ACTUAL)