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

Spinal Cord Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00447343
• Other study ID #: R-04-022
• Secondary ID: 09994
• Status: Completed
• Phase: N/A
• First received: March 13, 2007
• Last updated: August 25, 2017
• Start date: September 2008
• Est. completion date: August 2012

Study information

• Verified date: August 2017
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: August 2012
• Est. primary completion date: January 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bone Marrow Diseases
• Spinal Cord Diseases

Intervention

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

Locations

Country	Name	City	State
Canada	London Health Sciences Center	London	Ontario

Sponsors (3)

Lead Sponsor	Collaborator
Lawson Health Research Institute	American Association of Neurological Surgeons, The Physicians' Services Incorporated Foundation

Country where clinical trial is conducted

Canada, 

References & Publications (11)

BRAIN WR, NORTHFIELD D, WILKINSON M. The neurological manifestations of cervical spondylosis. Brain. 1952 Jun;75(2):187-225. — View Citation

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. — View Citation

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

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. — View Citation

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

LaRocca H. Cervical spondylotic myelopathy: natural history. Spine (Phila Pa 1976). 1988 Jul;13(7):854-5. Review. — View Citation

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. — View Citation

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 (Phila Pa 1976). 2001 Jun 1;26(11):1238-45. — View Citation

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

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. — View Citation

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 (Phila Pa 1976). 1992 Nov;17(11):1281-4. — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure the volume of activation and signal intensity using fMRI and MRS.		2 scans 6 months apart
Secondary	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).		2 scans 6 months apart