The Natural History of Traumatic Spinal Cord Injury Using fMRI, MRS and DTI - Full Text View

Sponsors and Collaborators:	Lawson Health Research Institute The Physicians' Services Incorporated Foundation
Information provided by:	Lawson Health Research Institute
ClinicalTrials.gov Identifier:	NCT00790361

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

MedlinePlus related topics: MRI Scans Spinal Cord Injuries

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, 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

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	20
Study Start Date:	January 2009
Estimated Study Completion Date:	January 2010

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 Sciecnes 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

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
London, Ontario, Canada, N6A-5A5

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:

Aito S, D'Andrea M, Werhagen L, Farsetti L, Cappelli S, Bandini B, Di Donna V. Neurological and functional outcome in traumatic central cord syndrome. Spinal Cord. 2007 Apr;45(4):292-7. Epub 2006 Jun 13.

Clark CA, Werring DJ. Diffusion tensor imaging in spinal cord: methods and applications - a review. NMR Biomed. 2002 Nov-Dec;15(7-8):578-86. Review.

De Stefano N, Matthews PM, Arnold DL. Reversible decreases in N-acetylaspartate after acute brain injury. Magn Reson Med. 1995 Nov;34(5):721-7.

Dvorak MF, Fisher CG, Hoekema J, Boyd M, Noonan V, Wing PC, Kwon BK. Factors predicting motor recovery and functional outcome after traumatic central cord syndrome: a long-term follow-up. Spine. 2005 Oct 15;30(20):2303-11. Erratum in: Spine. 2006 May 15;31(11):1289. Kwon, Brian [corrected to Kwon, Brian K].

Holly LT, Dong Y, Albistegui-DuBois R, Marehbian J, Dobkin B. Cortical reorganization in patients with cervical spondylotic myelopathy. J Neurosurg Spine. 2007 Jun;6(6):544-51.

Kassem MN, Bartha R. Quantitative proton short-echo-time LASER spectroscopy of normal human white matter and hippocampus at 4 Tesla incorporating macromolecule subtraction. Magn Reson Med. 2003 May;49(5):918-27.

Pickett GE, Campos-Benitez M, Keller JL, Duggal N. Epidemiology of traumatic spinal cord injury in Canada. Spine. 2006 Apr 1;31(7):799-805.

Puri BK, Smith HC, Cox IJ, Sargentoni J, Savic G, Maskill DW, Frankel HL, Ellaway PH, Davey NJ. The human motor cortex after incomplete spinal cord injury: an investigation using proton magnetic resonance spectroscopy. J Neurol Neurosurg Psychiatry. 1998 Nov;65(5):748-54.

Yamazaki T, Yanaka K, Fujita K, Kamezaki T, Uemura K, Nose T. Traumatic central cord syndrome: analysis of factors affecting the outcome. Surg Neurol. 2005 Feb;63(2):95-9; discussion 99-100.

Responsible Party:	London Health Sciences Centre ( Neil Duggal, MSc, MD, FRCS(C) )
Study ID Numbers:	R-07-396, 13652
Study First Received:	November 12, 2008
Last Updated:	November 12, 2008
ClinicalTrials.gov Identifier:	NCT00790361
Health Authority:	Canada: Ethics Review Committee; Canada: Health Canada

Keywords provided by Lawson Health Research Institute:

cervical spondylotic myelopathy
spinal cord compression
magnetic resonance spectroscopy
functional magnetic resonance imaging
brain plasticity

Study placed in the following topic categories:

Spinal Cord Injuries
Spinal Cord Diseases
Spinal Cord Compression
Wounds and Injuries

Disorders of Environmental Origin
Central Nervous System Diseases
Trauma, Nervous System
Central Cord Syndrome

Additional relevant MeSH terms:

Pathologic Processes
Disease
Syndrome
Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009