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

August 25, 2017 updated by: Lawson Health Research Institute

Mapping of the Sensorimotor Cortex in Cervical Myelopathy Using Functional Magnetic Resonance Imaging and Magnetic Resonance Spectroscopy

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

35

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

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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measure the volume of activation and signal intensity using fMRI and MRS.
Time Frame: 2 scans 6 months apart
2 scans 6 months apart

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), Nurick, ASIA/ISCOS Impairment Scale, Short Form Health Survey (SF-36) and the Neck Disability Index (NDI).
Time Frame: 2 scans 6 months apart
2 scans 6 months apart

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
American Association of Neurological Surgeons

Investigators

  • Principal Investigator: Neil Duggal, M.D., M.Sc., London Health Sciences Center
  • Principal Investigator: Robert Bartha, Ph.D, Western University, Canada

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)

September 1, 2008

Primary Completion (Actual)

January 1, 2011

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

March 13, 2007

First Submitted That Met QC Criteria

March 13, 2007

First Posted (Estimate)

March 14, 2007

Study Record Updates

Last Update Posted (Actual)

August 28, 2017

Last Update Submitted That Met QC Criteria

August 25, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-04-022
  • 09994

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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