Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-27 @ 10:17 PM
Study NCT ID:
NCT00790361
Status:
COMPLETED
Last Update Posted:
2017-08-28
First Post:
2008-11-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Natural History of Traumatic Spinal Cord Injury Using fMRI, MRS and DTI
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020210', 'term': 'Central Cord Syndrome'}, {'id': 'D013117', 'term': 'Spinal Cord Compression'}], 'ancestors': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-06-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-08', 'completionDateStruct': {'date': '2010-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-08-25', 'studyFirstSubmitDate': '2008-11-12', 'studyFirstSubmitQcDate': '2008-11-12', 'lastUpdatePostDateStruct': {'date': '2017-08-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-11-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measure the volume of activation, signal intensity and levels of NAA and glutamate using fMRI, MRS and DTI.', 'timeFrame': 'acutely (up to 48 hours after injury), subacutely (15 days after injury), and late (6 months after injury)'}], 'secondaryOutcomes': [{'measure': '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).', 'timeFrame': 'Acutely (up to 48 hours after injury), subacutely (15 days after injury), and late (6 months after injury)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cervical spondylotic myelopathy', 'spinal cord compression', 'magnetic resonance spectroscopy', 'functional magnetic resonance imaging', 'brain plasticity'], 'conditions': ['Central Cord Syndrome']}, 'referencesModule': {'references': [{'pmid': '16773038', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '12489104', 'type': 'BACKGROUND', 'citation': 'Clark 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.'}, {'pmid': '8544693', 'type': 'BACKGROUND', 'citation': 'De 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.'}, {'pmid': '16227894', 'type': 'BACKGROUND', 'citation': 'Dvorak 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.'}, {'pmid': '17561743', 'type': 'BACKGROUND', 'citation': 'Holly 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.'}, {'pmid': '12704775', 'type': 'BACKGROUND', 'citation': 'Kassem 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.'}, {'pmid': '16582854', 'type': 'BACKGROUND', 'citation': 'Pickett 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.'}, {'pmid': '9810950', 'type': 'BACKGROUND', 'citation': 'Puri 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.'}, {'pmid': '15680638', 'type': 'BACKGROUND', 'citation': 'Yamazaki 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.'}]}, 'descriptionModule': {'briefSummary': '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.\n\nResearch 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.\n\nIt 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.\n\nWe 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.', 'detailedDescription': '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.\n\nTen 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.\n\nClinical 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '30 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Ten patients and ten controls will be recruited from the Clinical Neurological Sciences outpatient clinic at the London Health Sciences Centre, University Campus', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* between 30 and 85 years of age\n* right handed\n* with normal/corrected hearing and vision\n* fluent in reading and speaking Canadian or American English\n* able to follow simple task instructions\n* able to maintain standardized movements\n* available to return for the 15 day and 6 month imaging sessions\n* competent to give consent\n\nExclusion Criteria:\n\n* must not have any other neurological disorder or systemic disease that may affect neurologic function\n* not have any potential magnetic metal fragments in their body\n* suffering from claustrophobia\n* having a pacemaker or other electronic implants\n* have been or currently is a welder or soldier\n* have been injured by a metallic object that has not been removed\n* pregnant or trying to conceive\n* have cerebral aneurysm clips'}, 'identificationModule': {'nctId': 'NCT00790361', 'briefTitle': 'The Natural History of Traumatic Spinal Cord Injury Using fMRI, MRS and DTI', 'organization': {'class': 'OTHER', 'fullName': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's"}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': '13652'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control', 'description': 'Controls (healthy volunteers) will have two scans (fMRI, MRS and DTI) six months apart to determine reproducibility.\n\nA blinded investigator will administer JOA, ASIA/ISCOS, NDI and SF-36 prior to the scan at all time points.'}, {'label': 'CCS Participants', 'description': '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).\n\nA blinded investigator will administer JOA, ASIA/ISCOS, NDI and SF-36 prior to the scan at all time points.'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'N6A-5A5', 'city': 'London', 'state': 'Ontario', 'country': 'Canada', 'facility': 'London Health Sciences Center, University Campus', 'geoPoint': {'lat': 42.98339, 'lon': -81.23304}}], 'overallOfficials': [{'name': 'Neil Duggal, M.D., MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'London Health Research Institute, London Health Sciences Centre'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's", 'class': 'OTHER'}, 'collaborators': [{'name': "The Physicians' Services Incorporated Foundation", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}