Reorganization of Brain Functions in Patients With Cervical Myelopathy Using fMRI and MRS - Full Text View

Sponsors and Collaborators:	Lawson Health Research Institute The Physicians' Services Incorporated Foundation American Association of Neurological Surgeons
Information provided by:	Lawson Health Research Institute
ClinicalTrials.gov Identifier:	NCT00447343

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

MedlinePlus related topics: Nuclear Scans Spinal Cord Diseases

U.S. FDA Resources

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

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	35
Study Start Date:	February 2004
Estimated Study Completion Date:	August 2010
Estimated Primary Completion Date:	August 2009 (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 Sciecnes 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

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	Robarts Research Institute

More Information

Publications:

BRAIN WR, NORTHFIELD D, WILKINSON M. The neurological manifestations of cervical spondylosis. Brain. 1952 Jun;75(2):187-225. No abstract available.

Bunge RP, Puckett WR, Becerra JL, Marcillo A, Quencer RM. Observations on the pathology of human spinal cord injury. A review and classification of 22 new cases with details from a case of chronic cord compression with extensive focal demyelination. Adv Neurol. 1993;59:75-89. No abstract available.

Carol MP, Ducker TB. Cervical spondylitic myelopathies: surgical treatment. J Spinal Disord. 1988;1(1):59-65.

Curt A, Alkadhi H, Crelier GR, Boendermaker SH, Hepp-Reymond MC, Kollias SS. Changes of non-affected upper limb cortical representation in paraplegic patients as assessed by fMRI. Brain. 2002 Nov;125(Pt 11):2567-78.

Hunt WE. Cervical spondylosis: natural history and rare indications for surgical decompression. Clin Neurosurg. 1980;27:466-80.

LaRocca H. Cervical spondylotic myelopathy: natural history. Spine. 1988 Jul;13(7):854-5. Review. No abstract available.

Lunsford LD, Bissonette DJ, Jannetta PJ, Sheptak PE, Zorub DS. Anterior surgery for cervical disc disease. Part 1: Treatment of lateral cervical disc herniation in 253 cases. J Neurosurg. 1980 Jul;53(1):1-11.

Morio Y, Teshima R, Nagashima H, Nawata K, Yamasaki D, Nanjo Y. Correlation between operative outcomes of cervical compression myelopathy and mri of the spinal cord. Spine. 2001 Jun 1;26(11):1238-45.

Rowland LP. Surgical treatment of cervical spondylotic myelopathy: time for a controlled trial. Neurology. 1992 Jan;42(1):5-13. Review.

Teramoto T, Ohmori K, Takatsu T, Inoue H, Ishida Y, Suzuki K. Long-term results of the anterior cervical spondylodesis. Neurosurgery. 1994 Jul;35(1):64-8.

Yonenobu K, Hosono N, Iwasaki M, Asano M, Ono K. Laminoplasty versus subtotal corpectomy. A comparative study of results in multisegmental cervical spondylotic myelopathy. Spine. 1992 Nov;17(11):1281-4.

Responsible Party:	London Health Sciences Centre ( Neil Duggal, MSc, MD, FRCS(C) )
Study ID Numbers:	R-04-022, 09994
Study First Received:	March 13, 2007
Last Updated:	November 12, 2008
ClinicalTrials.gov Identifier:	NCT00447343
Health Authority:	Canada: Ethics Review Committee

Keywords provided by Lawson Health Research Institute:

Functional MRI
Cervical myelopathy
Cervical radiculopathy
Brain plasticity and regeneration

Study placed in the following topic categories:

Spinal Cord Diseases
Radiculopathy
Central Nervous System Diseases

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009