Reorganization of Brain Functions in Patients With Cervical Myelopathy Using fMRI and MRS

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  Recruiting
Sponsor:
Collaborators:
The Physicians' Services Incorporated Foundation
American Association of Neurological Surgeons
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00447343
First received: March 13, 2007
Last updated: June 2, 2010
Last verified: June 2010
  Purpose

Decompressive surgery to relieve symptoms of spinal cord compression due to dysfunction, such as arthritis, has proved variable in success. Past research has reported that approximately one-third of surgery patients improved, one-third remained the same and one-third worsened. Currently, there are no reliable tests that can predict the outcome following surgery. We are hoping that this study will change that.

Using functional MRI (fMRI), we wish to investigate the relationship between clinical symptoms and the recovery of brain activation following surgery. One can also track the concentrations of different chemicals (metabolites) by using magnetic resonance spectroscopy (MRS). We hypothesize that the recovery of normal brain activation patterns will coincide with clinical improvement. Our objective in this study is to explore the potential role of fMRI as a tool to prognose patients with cervical myelopathy.

Twenty-five patients with cervical myelopathy will be imaged using a high-powered (3 Tesla) fMRI scanner before and six months following surgery. In addition, ten healthy controls will be imaged to provide a baseline measure. Both the patient and control groups will complete questionnaires at the time of their scans. These will provide information concerning the subjective experience of the individuals throughout recovery. We will compare brain activation patterns of control and patient groups to investigate how the brain heals following decompressive surgery.


Condition Intervention
Spinal Cord Diseases
Procedure: Decompressive cervical spine surgery
Procedure: fMRI and MRS scan

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Mapping of the Sensorimotor Cortex in Cervical Myelopathy Using Functional Magnetic Resonance Imaging and Magnetic Resonance Spectroscopy

Resource links provided by NLM:


Further study details as provided by Lawson Health Research Institute:

Primary Outcome Measures:
  • Measure the volume of activation and signal intensity using fMRI and MRS. [ Time Frame: 2 scans 6 months apart ] [ 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), Nurick, ASIA/ISCOS Impairment Scale, Short Form Health Survey (SF-36) and the Neck Disability Index (NDI). [ Time Frame: 2 scans 6 months apart ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: September 2008
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Treatment group

Patients with cervical myelopathy undergoing decompressive cervical spine surgery will have two scans (pre-operatively and 6 months post-operatively).

A blinded investigator will administer questionnaires at each time point.

Procedure: Decompressive cervical spine surgery

Treatment group (25 patients) will undergo decompressive anterior cervical spine surgery

Healthy volunteers will ONLY undergo two scans 6 months apart.

Procedure: fMRI and MRS scan
A scan pre-op and 6 months post-op.
Control group

Healthy Volunteers will have two scans 6 months apart.

A blinded investigator will administer questionnaires at each time point.

Procedure: fMRI and MRS scan
A scan pre-op and 6 months post-op.

Detailed Description:

Degenerative arthritis is a universal concomitant of human aging, affecting 51% of the adult population. Arthritis of the spine is the most common cause of acquired spinal cord dysfunction and can manifest in subtle symptoms, such as diminished balance and dexterity, or profound symptoms, such as paralysis and incontinence. In cases where dysfunction results in severe spinal cord compression, surgery is performed. However, surgical outcomes are not always beneficial. Past research has reported that approximately one-third of surgery patients improved, one-third remained the same and one-third worsened. Currently, there are no reliable tests that can predict outcome following surgery. We are hoping that this study will change that.

Twenty-five patients will undergo 45 minute imaging sessions pre-operatively and six months post-operatively. Ten controls will undergo 45 minute imaging sessions twice to provide a baseline comparison and reproducibility. During each session, one motor task (finger tapping) and 1 sensory task (hand brushing) will be performed for 2 minutes at 10 second intervals. We wish to compare the change in volume extent, and location, and intensity of brain activation levels before and after surgery. We will also compare fMRI signal response differences between controls and patients. We hypothesize that the degree to which brain activation shifts towards normalcy (that of controls) will correlate with the degree of neurological recovery postoperatively.

Data will be analyzed using software developed at the Robarts Research Institute.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Twenty-five 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:

  • All Participants will be

    1. between 18 and 75 years of age
    2. right handed
    3. with normal/corrected hearing and vision
    4. native speakers of Canadian or American English
    5. must be competent to give consent.
  • Cervical Myelopathy Patients will be:

    1. Undergoing a first time cervical decompression for cervical spondylosis causing myelopathy secondary to spinal cord compression which is documented by a diagnostic procedure ( CT and/or MRI ).
    2. Spinal cord compression from the cervicomedullary junction to the C7-T1 disc level.
    3. Ability and willingness to participate in a follow-up fMRI study at 6 months following surgery.
  • Healthy Control Volunteers will be:

    1. Volunteers from the Dept. of Clinical Neurological Sciences

Exclusion Criteria:

  • Cervical Myelopathy Patients must not:

    1. have any pre-existing medical conditions (e.g. significant renal or hepatic disease)

  • Healthy control volunteers must not:

    1. have a pre-existing diagnosis or history of a neurological disorder.

  • All participants must not:

    1. have any potential magnetic metal fragments in their body except for titanium implants placed at the time of surgery will be excluded. Dental work is non-magnetic and does not require participant exclusion.

  • Participants who fall into the following categories will not be tested in the 4T scanner:

    1. claustrophobia
    2. pacemaker or other electronic implants
    3. being a welder or soldier
    4. having been injured by a metallic object that was not removed
    5. being pregnant or trying to conceive
    6. women of childbearing potential who are not using an effective method of contraception
    7. 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: NCT00447343

Contacts
Contact: Izabela Kowalczyk, BHSc 519-695-8500 ext 35456 ikowalcz@uwo.ca
Contact: Jennifer Moore 519-685-8500 ext 32926 jennifer.moore@lhsc.on.ca

Locations
Canada, Ontario
London Health Sciences Center Recruiting
London, Ontario, Canada, N6A 5A5
Contact: Izabela Kowalczyk, BHSc    519-685-8500 ext 35456    ikowalcz@uwo.ca   
Contact: Jennifer Moore    518-685-8500 ext 32926    jennifer.moore@lhsc.on.ca   
Sub-Investigator: Joseph Gati, M.Sc.         
Sub-Investigator: Donald Lee, M.D. FRCP         
Sub-Investigator: Ravi Menon, Ph.D.         
Sub-Investigator: Marie Fink, B.MSc         
Sponsors and Collaborators
Lawson Health Research Institute
The Physicians' Services Incorporated Foundation
American Association of Neurological Surgeons
Investigators
Principal Investigator: Neil Duggal, M.D., M.Sc. London Health Sciences Center
Principal Investigator: Robert Bartha, Ph.D University of Western Ontario, Canada
  More Information

Publications:

Responsible Party: Neil Duggal, MSc, MD, FRCS(C), London Health Sciences Centre
ClinicalTrials.gov Identifier: NCT00447343     History of Changes
Other Study ID Numbers: R-04-022, 09994
Study First Received: March 13, 2007
Last Updated: June 2, 2010
Health Authority: Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:
Functional MRI
Cervical myelopathy
Cervical radiculopathy
Brain plasticity and regeneration

Additional relevant MeSH terms:
Bone Marrow Diseases
Spinal Cord Diseases
Hematologic Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on July 23, 2014