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

NCT00447343 | Completed

• 2 other identifiers: R-04-02209994
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Cord Diseases

Keywords

Functional MRI; Cervical myelopathy; Cervical radiculopathy; Brain plasticity and regeneration

Outcome Measures

Primary Outcomes (1)

• Measure the volume of activation and signal intensity using fMRI and MRS.

  2 scans 6 months apart

Secondary Outcomes (1)

• 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

Study Arms (2)

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; Procedure: fMRI and MRS scan

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

Interventions

Decompressive cervical spine surgery PROCEDURE

Treatment group (25 patients) will undergo decompressive anterior cervical spine surgery Healthy volunteers will ONLY undergo two scans 6 months apart.

Treatment group

fMRI and MRS scan PROCEDURE

A scan pre-op and 6 months post-op.

Control group; Treatment group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• All Participants will be
• between 18 and 75 years of age
• right handed
• with normal/corrected hearing and vision
• native speakers of Canadian or American English
• must be competent to give consent.
• Cervical Myelopathy Patients will be:
• 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 ).
• Spinal cord compression from the cervicomedullary junction to the C7-T1 disc level.
• Ability and willingness to participate in a follow-up fMRI study at 6 months following surgery.
• Healthy Control Volunteers will be:
• Volunteers from the Dept. of Clinical Neurological Sciences

You may not qualify if:

• Cervical Myelopathy Patients must not:
• \. have any pre-existing medical conditions (e.g. significant renal or hepatic disease)
• Healthy control volunteers must not:
• \. have a pre-existing diagnosis or history of a neurological disorder.
• All participants must not:
• Participants who fall into the following categories will not be tested in the 4T scanner:
• claustrophobia
• pacemaker or other electronic implants
• being a welder or soldier
• having been injured by a metallic object that was not removed
• being pregnant or trying to conceive
• women of childbearing potential who are not using an effective method of contraception
• cerebral aneurysm clips.

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• The Physicians' Services Incorporated Foundation: collaborator
• American Association of Neurological Surgeons: collaborator

Study Sites (1)

London Health Sciences Center

London, Ontario, N6A 5A5, Canada

Location

Related Publications (11)

• BRAIN WR, NORTHFIELD D, WILKINSON M. The neurological manifestations of cervical spondylosis. Brain. 1952 Jun;75(2):187-225. doi: 10.1093/brain/75.2.187. No abstract available.

  PMID: 14934989 BACKGROUND

• 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.

  PMID: 8420126 BACKGROUND

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

  PMID: 2980063 BACKGROUND

• 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. doi: 10.1093/brain/awf250.

  PMID: 12390981 BACKGROUND

• Hunt WE. Cervical spondylosis: natural history and rare indications for surgical decompression. Clin Neurosurg. 1980;27:466-80. doi: 10.1093/neurosurgery/27.cn_suppl_1.466.

  PMID: 7273568 BACKGROUND

• LaRocca H. Cervical spondylotic myelopathy: natural history. Spine (Phila Pa 1976). 1988 Jul;13(7):854-5. doi: 10.1097/00007632-198807000-00028. No abstract available.

  PMID: 3057650 BACKGROUND

• 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. doi: 10.3171/jns.1980.53.1.0001.

  PMID: 7411195 BACKGROUND

• 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. doi: 10.1097/00007632-200106010-00012.

  PMID: 11389390 BACKGROUND

• Rowland LP. Surgical treatment of cervical spondylotic myelopathy: time for a controlled trial. Neurology. 1992 Jan;42(1):5-13. doi: 10.1212/wnl.42.1.5.

  PMID: 1734322 BACKGROUND

• 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. doi: 10.1227/00006123-199407000-00010.

  PMID: 7936154 BACKGROUND

• 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.

  PMID: 1462201 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Diseases; Radiculopathy

Condition Hierarchy (Ancestors)

Central Nervous System Diseases; Nervous System Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases

Study Officials

• Neil Duggal, M.D., M.Sc.

  London Health Sciences Center

  PRINCIPAL INVESTIGATOR

• Robert Bartha, Ph.D

  Western University, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2007
• First Posted: March 14, 2007
• Study Start: September 1, 2008
• Primary Completion: January 1, 2011
• Study Completion: August 1, 2012
• Last Updated: August 28, 2017

Record last verified: 2017-08

Locations

CA (1)