Spinal Cord DiseasesNCT00447343
Reorganization of Brain Functions in Patients With Cervical Myelopathy Using fMRI and MRS
An observational study of Spinal Cord Diseases, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Diseases
- What is being tested?
- Decompressive cervical spine surgery and fMRI and MRS scan
- Type of treatment
- Surgery or procedure
- How many people
- 35 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2008to Aug 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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.
Show all 12Show fewer
- 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
Who cannot join
- 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.
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Spinal Cord Diseases
- Being tested
- Decompressive cervical spine surgery, fMRI and MRS scan
- Keywords
- Functional MRI, Cervical myelopathy, Cervical radiculopathy, Brain plasticity and regeneration
- Medical subject headings
- Spinal Cord Diseases, Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decompressive cervical spine surgeryProcedure or 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 scanProcedure or surgery
A scan pre-op and 6 months post-op.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: fMRI and MRS scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the volume of activation and signal intensity using fMRI and MRS.
Measured: 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).
Measured: 2 scans 6 months apart
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2007 (estimated)
- Study startSep 2008
- Primary completionJan 2011
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord DiseasesStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation, American Association of Neurological Surgeons
- Responsible party
- Sponsor
- Investigators
- Neil Duggal, M.D., M.Sc., Principal investigator, London Health Sciences CenterRobert Bartha, Ph.D, Principal investigator, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00447343
- Sponsor's protocol ID
- R-04-022
- Other IDs
- 09994
- Status last verified
- Aug 2017
- First submitted
- 13 Mar 2007
- Last updated
- 28 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 14934989Bunge 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.
PubMed 8420126Carol MP, Ducker TB. Cervical spondylitic myelopathies: surgical treatment. J Spinal Disord. 1988;1(1):59-65.
PubMed 2980063Curt 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.
PubMed 12390981Hunt 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.
PubMed 7273568LaRocca 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.
PubMed 3057650Lunsford 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.
PubMed 7411195Morio 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.
PubMed 11389390Rowland 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.
PubMed 1734322Teramoto 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.
PubMed 7936154Yonenobu 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.
PubMed 1462201
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mapping of the Sensorimotor Cortex in Cervical Myelopathy Using Functional Magnetic Resonance Imaging and Magnetic Resonance Spectroscopy
- ClinicalTrials.gov ID
- NCT00447343
- Acronym / sponsor ID
- R-04-022
- Conditions
- Spinal Cord Diseases
- Keywords
- Functional MRI, Cervical myelopathy, Cervical radiculopathy, Brain plasticity and regeneration
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- The Physicians' Services Incorporated Foundation, American Association of Neurological Surgeons
- Study start
- Sep 2008 (actual)
- Primary completion
- Jan 2011 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 14 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | – | Procedure: Decompressive cervical spine surgery, Procedure: fMRI and MRS scanPatients 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. |
| Control group | – | Procedure: fMRI and MRS scanHealthy Volunteers will have two scans 6 months apart. A blinded investigator will administer questionnaires at each time point. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (12 listed)
- All Participants will be
- Cervical Myelopathy Patients will be:
- Healthy Control Volunteers will be:
Key exclusion criteria (14 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decompressive cervical spine surgeryTreatment group (25 patients) will undergo decompressive anterior cervical spine surgery Healthy volunteers will ONLY undergo two scans 6 months apart. | Procedure or surgery | Treatment group |
| fMRI and MRS scanA scan pre-op and 6 months post-op. | Procedure or surgery | Control group, Treatment group |
Primary outcome
Measure the volume of activation and signal intensity using fMRI and MRS.
Time frame: 2 scans 6 months apart
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2017.
- Background: PubMed 14934989BRAIN 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.
- Background: PubMed 8420126Bunge 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.
- Background: PubMed 2980063Carol MP, Ducker TB. Cervical spondylitic myelopathies: surgical treatment. J Spinal Disord. 1988;1(1):59-65.
- Background: PubMed 12390981Curt 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.
- Background: PubMed 7273568Hunt 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.
- Background: PubMed 3057650LaRocca 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.
- Background: PubMed 7411195Lunsford 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.
- Background: PubMed 11389390Morio 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.
- Background: PubMed 1734322Rowland 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.
- Background: PubMed 7936154Teramoto 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.
- Background: PubMed 1462201Yonenobu 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Neil Duggal, M.D., M.Sc. principal investigator
London Health Sciences Center
Robert Bartha, Ph.D principal investigator
Western University, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Diseases, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure the volume of activation and signal intensity using fMRI and MRS. (time frame: 2 scans 6 months apart). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00447343, which also lists 11 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2017.