Central Cord SyndromeNCT00790361
The Natural History of Traumatic Spinal Cord Injury Using fMRI, MRS and DTI
An observational study of Central Cord Syndrome, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
Trial summary
Traumatic spinal cord injury is a common injury to the spine and can lead to a clinical syndrome called central cord syndrome (CCS). CCS is an incomplete spinal cord injury where one starts to lose more motor function in the upper rather than lower extremities. Read more about this study
- Who is it for?
- Ages 30 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Central Cord Syndrome
- How many people
- 20 participants
- Where
- 1 siteCanada
- Study dates
- 18 Jun 2009to 31 Jan 2010
- 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 30 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Ten 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
- between 30 and 85 years of age
- right handed
- with normal/corrected hearing and vision
- fluent in reading and speaking Canadian or American English
- able to follow simple task instructions
- able to maintain standardized movements
- available to return for the 15 day and 6 month imaging sessions
- competent to give consent
Who cannot join
- must not have any other neurological disorder or systemic disease that may affect neurologic function
- not have any potential magnetic metal fragments in their body
- suffering from claustrophobia
- having a pacemaker or other electronic implants
- have been or currently is a welder or soldier
- have been injured by a metallic object that has not been removed
- pregnant or trying to conceive
- have cerebral aneurysm clips
Trial locations and contacts
1 site in 1 country.
Canada1 site
London Health Sciences Center, University Campus
London, Ontario, N6A-5A5
About this study
Official title: Mapping the Natural History of Traumatic Spinal Cord Injury in the Sensorimotor Cortex Using Functional Magnetic Resonance Imaging, Magnetic Resonance Spectroscopy and Diffusion Tensor Imaging
Traumatic spinal cord injury is a common injury to the spine and can lead to a clinical syndrome called central cord syndrome (CCS). CCS is an incomplete spinal cord injury where one starts to lose more motor function in the upper rather than lower extremities. It affects a wide range of the population from the young to the old. However, the natural history of CCS is poorly understood.
Research has shown that the injury resulting in CCS might be due to the pinching or compressing of the spinal cord. This creates damage to a part of the spinal cord and creates difficulties in the signal getting through. We believe that we can gain a better understanding of the natural history of incomplete spinal cord injury as well as the recovery process.
Read more
It is possible to track many changes in the brain and motor function through a variety of methods. One can track the concentrations of different chemicals (metabolites) by using magnetic resonance spectroscopy (MRS), changes in brain activation by using functional magnetic resonance imaging (fMRI) and thread-like nerve fibers in the spine by using diffusion tensor imaging (DTI). In our study we will be detecting differences in brain metabolism and activation of different parts of the brain during specific movement and in the nerve fibers in the brain.
We hypothesize that there will be decreased levels of N-acetylaspartate (NAA, a putative marker of neuronal function) and decreased levels of glutamate (the primary excitatory neurotransmitter) in the motor cortex in patients with CCS when compared with controls. Over time, we hypothesize that the normalization of metabolite levels will correlate with the extent of neurologic recovery. We also hypothesize a reorganization of brain activation patterns with time such that patients will show increased volumes of activation in the motor cortex with recovery and that this will correlate with the extent of neurologic outcome. Over time, we predict that there will be normalization of the fibre track anatomy that will correlate with neurological recovery.
Read the detailed description
The long-term goal of this project is to develop predictors of neurological recovery based on brain metabolism, brain activation patterns, and fibre tracks in patients with traumatic CCS. The objective of this preliminary study is to evaluate metabolic changes, brain activation pattern reorganization and altered spinal cord fibre tracks in patients suffering from traumatic CCS to gain a better understanding of the natural history of this condition. Magnetic resonance spectroscopy (MRS), functional magnetic resonance imaging (fMRI), and diffusion tensor imaging (DTI) will be used to investigate the changes in brain metabolite concentrations, cerebral cortical activation, and fibre tract anatomy, respectively, in patients and controls.
Ten patients having traumatic CCS will be recruited from the Clinical Neurological Sciences Department at the London Health Sciences Centre, University Campus. All participants will undergo an fMRI, MRS and DTI scan of the motor cortex to measure the volume of activation, signal intensity and levels of NAA and glutamate. The CCS participants will have three scans, one acutely (up to 48 hours after injury), one subacutely (15 days after injury), and one late (6 months after injury). Healthy volunteers will have two scans six months apart to determine reproducibility.
Clinical changes will be measured using validated disease specific scoring instruments including the Japanese Orthopedic Association scale (JOA), ASIA/ISCOS Impairment Scale, and the Neck Disability Index (NDI). General quality of life will be measured using the 36-item Short-Form Health Survey (SF-36). A blinded investigator will administer these instruments prior to the scan at all time points.
- Conditions
- Central Cord Syndrome
- Keywords
- cervical spondylotic myelopathy, spinal cord compression, magnetic resonance spectroscopy, functional magnetic resonance imaging, brain plasticity
- Medical subject headings
- Central Cord Syndrome, Spinal Cord Compression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Control | Controls (healthy volunteers) will have two scans (fMRI, MRS and DTI) six months apart to determine reproducibility. A blinded investigator will administer JOA, ASIA/ISCOS, NDI and SF-36 prior to the scan at all time points. | |
| CCS Participants | CCS participants will have three scans (fMRI, MRS and DTI), one acutely (up to 48 hours after injury), one subacutely (15 days after injury), and one late (6 months after injury). A blinded investigator will administer JOA, ASIA/ISCOS, NDI and SF-36 prior to the scan at all time points. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the volume of activation, signal intensity and levels of NAA and glutamate using fMRI, MRS and DTI.
Measured: acutely (up to 48 hours after injury), subacutely (15 days after injury), and late (6 months after injury)
Secondary outcomes (1)
Clinical changes will be measured using validated disease specific scoring instruments including the Japanese Orthopedic Association scale (JOA), ASIA/ISCOS Impairment Scale, and the Neck Disability Index (NDI).
Measured: Acutely (up to 48 hours after injury), subacutely (15 days after injury), and late (6 months after injury)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2008 (estimated)
- Study start18 Jun 2009
- Primary completion31 Jan 2010
- Study completion31 Jan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Central Cord SyndromeStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 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
- Responsible party
- Sponsor
- Investigators
- Neil Duggal, M.D., MSc, Principal investigator, London Health Research Institute, London Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00790361
- Sponsor's protocol ID
- 13652
- Status last verified
- Aug 2017
- First submitted
- 12 Nov 2008
- Last updated
- 28 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Aito S, D'Andrea M, Werhagen L, Farsetti L, Cappelli S, Bandini B, Di Donna V. Neurological and functional outcome in traumatic central cord syndrome. Spinal Cord. 2007 Apr;45(4):292-7. doi: 10.1038/sj.sc.3101944. Epub 2006 Jun 13.
PubMed 16773038Clark CA, Werring DJ. Diffusion tensor imaging in spinal cord: methods and applications - a review. NMR Biomed. 2002 Nov-Dec;15(7-8):578-86. doi: 10.1002/nbm.788.
PubMed 12489104De Stefano N, Matthews PM, Arnold DL. Reversible decreases in N-acetylaspartate after acute brain injury. Magn Reson Med. 1995 Nov;34(5):721-7. doi: 10.1002/mrm.1910340511.
PubMed 8544693Dvorak MF, Fisher CG, Hoekema J, Boyd M, Noonan V, Wing PC, Kwon BK. Factors predicting motor recovery and functional outcome after traumatic central cord syndrome: a long-term follow-up. Spine (Phila Pa 1976). 2005 Oct 15;30(20):2303-11. doi: 10.1097/01.brs.0000182304.35949.11.
PubMed 16227894Holly LT, Dong Y, Albistegui-DuBois R, Marehbian J, Dobkin B. Cortical reorganization in patients with cervical spondylotic myelopathy. J Neurosurg Spine. 2007 Jun;6(6):544-51. doi: 10.3171/spi.2007.6.6.5.
PubMed 17561743Kassem MN, Bartha R. Quantitative proton short-echo-time LASER spectroscopy of normal human white matter and hippocampus at 4 Tesla incorporating macromolecule subtraction. Magn Reson Med. 2003 May;49(5):918-27. doi: 10.1002/mrm.10443.
PubMed 12704775Pickett GE, Campos-Benitez M, Keller JL, Duggal N. Epidemiology of traumatic spinal cord injury in Canada. Spine (Phila Pa 1976). 2006 Apr 1;31(7):799-805. doi: 10.1097/01.brs.0000207258.80129.03.
PubMed 16582854Puri BK, Smith HC, Cox IJ, Sargentoni J, Savic G, Maskill DW, Frankel HL, Ellaway PH, Davey NJ. The human motor cortex after incomplete spinal cord injury: an investigation using proton magnetic resonance spectroscopy. J Neurol Neurosurg Psychiatry. 1998 Nov;65(5):748-54. doi: 10.1136/jnnp.65.5.748.
PubMed 9810950Yamazaki T, Yanaka K, Fujita K, Kamezaki T, Uemura K, Nose T. Traumatic central cord syndrome: analysis of factors affecting the outcome. Surg Neurol. 2005 Feb;63(2):95-9; discussion 99-100. doi: 10.1016/j.surneu.2004.03.020.
PubMed 15680638
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 the Natural History of Traumatic Spinal Cord Injury in the Sensorimotor Cortex Using Functional Magnetic Resonance Imaging, Magnetic Resonance Spectroscopy and Diffusion Tensor Imaging
- ClinicalTrials.gov ID
- NCT00790361
- Acronym / sponsor ID
- 13652
- Conditions
- Central Cord Syndrome
- Keywords
- cervical spondylotic myelopathy, spinal cord compression, magnetic resonance spectroscopy, functional magnetic resonance imaging, brain plasticity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 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
- Study start
- 18 Jun 2009 (actual)
- Primary completion
- 31 Jan 2010 (actual)
- Study completion
- 31 Jan 2010 (actual)
- First posted
- 13 Nov 2008 (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.
Traumatic spinal cord injury is a common injury to the spine and can lead to a clinical syndrome called central cord syndrome (CCS). CCS is an incomplete spinal cord injury where one starts to lose more motor function in the upper rather than lower extremities. It affects a wide range of the population from the young to the old. However, the natural history of CCS is poorly understood.
Research has shown that the injury resulting in CCS might be due to the pinching or compressing of the spinal cord. This creates damage to a part of the spinal cord and creates difficulties in the signal getting through. We believe that we can gain a better understanding of the natural history of incomplete spinal cord injury as well as the recovery process.
It is possible to track many changes in the brain and motor function through a variety of methods. One can track the concentrations of different chemicals (metabolites) by using magnetic resonance spectroscopy (MRS), changes in brain activation by using functional magnetic resonance imaging (fMRI) and thread-like nerve fibers in the spine by using diffusion tensor imaging (DTI). In our study we will be detecting differences in brain metabolism and activation of different parts of the brain during specific movement and in the nerve fibers in the brain.
We hypothesize that there will be decreased levels of N-acetylaspartate (NAA, a putative marker of neuronal function) and decreased levels of glutamate (the primary excitatory neurotransmitter) in the motor cortex in patients with CCS when compared with controls. Over time, we hypothesize that the normalization of metabolite levels will correlate with the extent of neurologic recovery. We also hypothesize a reorganization of brain activation patterns with time such that patients will show increased volumes of activation in the motor cortex with recovery and that this will correlate with the extent of neurologic outcome. Over time, we predict that there will be normalization of the fibre track anatomy that will correlate with neurological recovery.
Detailed description
The long-term goal of this project is to develop predictors of neurological recovery based on brain metabolism, brain activation patterns, and fibre tracks in patients with traumatic CCS. The objective of this preliminary study is to evaluate metabolic changes, brain activation pattern reorganization and altered spinal cord fibre tracks in patients suffering from traumatic CCS to gain a better understanding of the natural history of this condition. Magnetic resonance spectroscopy (MRS), functional magnetic resonance imaging (fMRI), and diffusion tensor imaging (DTI) will be used to investigate the changes in brain metabolite concentrations, cerebral cortical activation, and fibre tract anatomy, respectively, in patients and controls.
Ten patients having traumatic CCS will be recruited from the Clinical Neurological Sciences Department at the London Health Sciences Centre, University Campus. All participants will undergo an fMRI, MRS and DTI scan of the motor cortex to measure the volume of activation, signal intensity and levels of NAA and glutamate. The CCS participants will have three scans, one acutely (up to 48 hours after injury), one subacutely (15 days after injury), and one late (6 months after injury). Healthy volunteers will have two scans six months apart to determine reproducibility.
Clinical changes will be measured using validated disease specific scoring instruments including the Japanese Orthopedic Association scale (JOA), ASIA/ISCOS Impairment Scale, and the Neck Disability Index (NDI). General quality of life will be measured using the 36-item Short-Form Health Survey (SF-36). A blinded investigator will administer these instruments prior to the scan at all time points.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | – | –Controls (healthy volunteers) will have two scans (fMRI, MRS and DTI) six months apart to determine reproducibility. A blinded investigator will administer JOA, ASIA/ISCOS, NDI and SF-36 prior to the scan at all time points. |
| CCS Participants | – | –CCS participants will have three scans (fMRI, MRS and DTI), one acutely (up to 48 hours after injury), one subacutely (15 days after injury), and one late (6 months after injury). A blinded investigator will administer JOA, ASIA/ISCOS, NDI and SF-36 prior to the scan at all time points. |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Ten 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 (8 listed)
- between 30 and 85 years of age
- right handed
- with normal/corrected hearing and vision
- fluent in reading and speaking Canadian or American English
- able to follow simple task instructions
Key exclusion criteria (8 listed)
- must not have any other neurological disorder or systemic disease that may affect neurologic function
- not have any potential magnetic metal fragments in their body
- suffering from claustrophobia
- having a pacemaker or other electronic implants
- have been or currently is a welder or soldier
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Measure the volume of activation, signal intensity and levels of NAA and glutamate using fMRI, MRS and DTI.
Time frame: acutely (up to 48 hours after injury), subacutely (15 days after injury), and late (6 months after injury)
1 secondary outcome
Clinical changes will be measured using validated disease specific scoring instruments including the Japanese Orthopedic Association scale (JOA), ASIA/ISCOS Impairment Scale, and the Neck Disability Index (NDI).
Time frame: Acutely (up to 48 hours after injury), subacutely (15 days after injury), and late (6 months after injury)
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 16773038Aito S, D'Andrea M, Werhagen L, Farsetti L, Cappelli S, Bandini B, Di Donna V. Neurological and functional outcome in traumatic central cord syndrome. Spinal Cord. 2007 Apr;45(4):292-7. doi: 10.1038/sj.sc.3101944. Epub 2006 Jun 13.
- Background: PubMed 12489104Clark CA, Werring DJ. Diffusion tensor imaging in spinal cord: methods and applications - a review. NMR Biomed. 2002 Nov-Dec;15(7-8):578-86. doi: 10.1002/nbm.788.
- Background: PubMed 8544693De Stefano N, Matthews PM, Arnold DL. Reversible decreases in N-acetylaspartate after acute brain injury. Magn Reson Med. 1995 Nov;34(5):721-7. doi: 10.1002/mrm.1910340511.
- Background: PubMed 16227894Dvorak MF, Fisher CG, Hoekema J, Boyd M, Noonan V, Wing PC, Kwon BK. Factors predicting motor recovery and functional outcome after traumatic central cord syndrome: a long-term follow-up. Spine (Phila Pa 1976). 2005 Oct 15;30(20):2303-11. doi: 10.1097/01.brs.0000182304.35949.11.
- Background: PubMed 17561743Holly LT, Dong Y, Albistegui-DuBois R, Marehbian J, Dobkin B. Cortical reorganization in patients with cervical spondylotic myelopathy. J Neurosurg Spine. 2007 Jun;6(6):544-51. doi: 10.3171/spi.2007.6.6.5.
- Background: PubMed 12704775Kassem MN, Bartha R. Quantitative proton short-echo-time LASER spectroscopy of normal human white matter and hippocampus at 4 Tesla incorporating macromolecule subtraction. Magn Reson Med. 2003 May;49(5):918-27. doi: 10.1002/mrm.10443.
- Background: PubMed 16582854Pickett GE, Campos-Benitez M, Keller JL, Duggal N. Epidemiology of traumatic spinal cord injury in Canada. Spine (Phila Pa 1976). 2006 Apr 1;31(7):799-805. doi: 10.1097/01.brs.0000207258.80129.03.
- Background: PubMed 9810950Puri BK, Smith HC, Cox IJ, Sargentoni J, Savic G, Maskill DW, Frankel HL, Ellaway PH, Davey NJ. The human motor cortex after incomplete spinal cord injury: an investigation using proton magnetic resonance spectroscopy. J Neurol Neurosurg Psychiatry. 1998 Nov;65(5):748-54. doi: 10.1136/jnnp.65.5.748.
- Background: PubMed 15680638Yamazaki T, Yanaka K, Fujita K, Kamezaki T, Uemura K, Nose T. Traumatic central cord syndrome: analysis of factors affecting the outcome. Surg Neurol. 2005 Feb;63(2):95-9; discussion 99-100. doi: 10.1016/j.surneu.2004.03.020.
Related trials for Central Cord Syndrome
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
RecruitingObservational study
Evaluation of Patients With HAM/TSP
HTLV-I Infection, Tropical Spastic Paraparesis
RecruitingObservational study
Investigating Complex Neurodegenerative Disorders Related to Amyotrophic Lateral Sclerosis and Frontotemporal Dementia
Frontotemporal Dementia, Amyotrophic Lateral Sclerosis
RecruitingPhase 2/3
Pilot Study of Galantamine to Treat Metabolic Syndrome in People With Chronic Traumatic Spinal Cord Injury (SCI)
Spinal Cord Injury, Traumatic Spinal Cord Injury
Active, not recruitingObservational study
Natural History of Shoulder Pathology in Manual Wheelchair Users
Paraplegia, Spinal Cord Injuries
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., MSc principal investigator
London Health Research Institute, London Health Sciences Centre
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 Central Cord Syndrome, 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 8 inclusion and 8 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, signal intensity and levels of NAA and glutamate using fMRI, MRS and DTI. (time frame: acutely (up to 48 hours after injury), subacutely (15 days after injury), and late (6 months after injury)). 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 NCT00790361, which also lists 9 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.