NCT00790361

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2009

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 13, 2008

Completed
7 months until next milestone

Study Start

First participant enrolled

June 18, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2010

Completed
Last Updated

August 28, 2017

Status Verified

August 1, 2017

Enrollment Period

8 months

First QC Date

November 12, 2008

Last Update Submit

August 25, 2017

Conditions

Keywords

cervical spondylotic myelopathyspinal cord compressionmagnetic resonance spectroscopyfunctional magnetic resonance imagingbrain plasticity

Outcome Measures

Primary Outcomes (1)

  • Measure the volume of activation, signal intensity and levels of NAA and glutamate using fMRI, MRS and DTI.

    acutely (up to 48 hours after injury), subacutely (15 days after injury), and late (6 months after injury)

Secondary Outcomes (1)

  • 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).

    Acutely (up to 48 hours after injury), subacutely (15 days after injury), and late (6 months after injury)

Study Arms (2)

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.

Eligibility Criteria

Age30 Years - 85 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

London Health Sciences Center, University Campus

London, Ontario, N6A-5A5, Canada

Location

Related Publications (9)

  • 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. doi: 10.1038/sj.sc.3101944. Epub 2006 Jun 13.

    PMID: 16773038BACKGROUND
  • 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. doi: 10.1002/nbm.788.

    PMID: 12489104BACKGROUND
  • 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. doi: 10.1002/mrm.1910340511.

    PMID: 8544693BACKGROUND
  • 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 (Phila Pa 1976). 2005 Oct 15;30(20):2303-11. doi: 10.1097/01.brs.0000182304.35949.11.

    PMID: 16227894BACKGROUND
  • 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. doi: 10.3171/spi.2007.6.6.5.

    PMID: 17561743BACKGROUND
  • 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. doi: 10.1002/mrm.10443.

    PMID: 12704775BACKGROUND
  • Pickett GE, Campos-Benitez M, Keller JL, Duggal N. Epidemiology of traumatic spinal cord injury in Canada. Spine (Phila Pa 1976). 2006 Apr 1;31(7):799-805. doi: 10.1097/01.brs.0000207258.80129.03.

    PMID: 16582854BACKGROUND
  • 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. doi: 10.1136/jnnp.65.5.748.

    PMID: 9810950BACKGROUND
  • 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. doi: 10.1016/j.surneu.2004.03.020.

    PMID: 15680638BACKGROUND

MeSH Terms

Conditions

Central Cord SyndromeSpinal Cord Compression

Condition Hierarchy (Ancestors)

Spinal Cord InjuriesSpinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Neil Duggal, M.D., MSc

    London Health Research Institute, London Health Sciences Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2008

First Posted

November 13, 2008

Study Start

June 18, 2009

Primary Completion

January 31, 2010

Study Completion

January 31, 2010

Last Updated

August 28, 2017

Record last verified: 2017-08

Locations