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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Lawson Health Research Institute.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00790361
First received: November 12, 2008
Last updated: June 2, 2010
Last verified: June 2010
  Purpose

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.


Condition
Central Cord Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: January 2012
Estimated Study Completion Date: January 2013
Groups/Cohorts
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.


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.

  Eligibility

Ages Eligible for Study:   30 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00790361

Contacts
Contact: Izabela Kowalczyk, BHSc 519-685-8500 ext 35456 ikowalcz@uwo.ca
Contact: Jennifer Long 519-685-8500 ext 32926 jennifern.long@lhsc.on.ca

Locations
Canada, Ontario
London Health Sciences Center, University Campus Not yet recruiting
London, Ontario, Canada, N6A-5A5
Contact: Izabela Kowalczyk, BHSc    519-685-8500 ext 35456    ikowalcz@uwo.ca   
Principal Investigator: Neil Duggal, MD FRCS(C)         
Sub-Investigator: Robert Bartha, HBSc, PhD         
Sub-Investigator: Craig K Jones, MSc PhD         
Sub-Investigator: Joseph S Gati, HBSc, MSc         
Sponsors and Collaborators
Lawson Health Research Institute
The Physicians' Services Incorporated Foundation
Investigators
Principal Investigator: Neil Duggal, M.D., MSc London Health Research Institute, London Health Sciences Centre
  More Information

Publications:

Responsible Party: Neil Duggal, MSc, MD, FRCS(C), London Health Sciences Centre
ClinicalTrials.gov Identifier: NCT00790361     History of Changes
Other Study ID Numbers: 13652
Study First Received: November 12, 2008
Last Updated: June 2, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
cervical spondylotic myelopathy
spinal cord compression
magnetic resonance spectroscopy
functional magnetic resonance imaging
brain plasticity

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

ClinicalTrials.gov processed this record on July 24, 2014