Reorganization of Brain Functions in Patients With Cervical Myelopathy Using fMRI and MRS
NCT ID: NCT00447343
Last Updated: 2017-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
35 participants
OBSERVATIONAL
2008-09-30
2012-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The Natural History of Traumatic Spinal Cord Injury Using fMRI, MRS and DTI
NCT00790361
Physiologic Studies of Spasticity
NCT00014976
Evaluation of the Visual Motor Task's Impact on the Behavior of a Neuronal and Spinal Network in Hemiplegic Patients
NCT03094572
Cerebral Reorganization in Cervical Myelopathy Measured by Navigated Transcranial Magnetic Stimulation
NCT03312608
Cortex Changes in Real/Imagined Movements in Amyotrophic Lateral Sclerosis (ALS)
NCT00809224
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
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.
Control group
Healthy Volunteers will have two scans 6 months apart.
A blinded investigator will administer questionnaires at each time point.
fMRI and MRS scan
A scan pre-op and 6 months post-op.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
75 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The Physicians' Services Incorporated Foundation
OTHER
American Association of Neurological Surgeons
OTHER
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Neil Duggal, M.D., M.Sc.
Role: PRINCIPAL_INVESTIGATOR
London Health Sciences Center
Robert Bartha, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Western University, Canada
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
London Health Sciences Center
London, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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. doi: 10.1093/brain/awf250.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
09994
Identifier Type: -
Identifier Source: secondary_id
R-04-022
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.