MR Spectroscopy as a Diagnostic and Outcome Measure in Pain and SCI
NCT ID: NCT00561782
Last Updated: 2014-09-17
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
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COMPLETED
94 participants
OBSERVATIONAL
2007-10-31
2010-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Group 1
Spinal cord injured with chronic central neuropathic pain.
No interventions assigned to this group
Group 2
Spinal cord injured without chronic central neuropathic pain.
No interventions assigned to this group
Group 3
Able-bodied without history of chronic pain of any type
No interventions assigned to this group
Group 4
Traumatically Brain Injured with a history of pain that onset after their TBI
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* fluent in English
* incomplete or complete traumatic SCI
* the injury must have occurred at least 2 years prior to entering the study
* the injury level must be above L1 and the subjects must have evidence of preserved distal cord functions (lower extremity reflexes and bulbocavernosus or anal wink reflexes)
* must have experienced chronic neuropathic pain at or below the level of injury for a minimum of six months
* must have moderately severe or greater neuropathic pain
* must be able to attend three sessions ranging from 2 to 6 hours over a period of 4 to 5 weeks
2. SCI and no neuropathic pain:
\- same as a., but participants in this group must NOT have unremitting moderate-severe pain and there will only be two sessions ranging from 2 to 6 hours over a period of 1 to 2 weeks
3. Able-bodied control subjects:
* fluent in English
* no history of chronic pain conditions
* no substantial brain or body injury
* must be able to attend two sessions ranging from 2 to 6 hours over a period of 1 to 2 weeks
Exclusion Criteria
* recent (one-year) history of alcohol or drug abuse
* known intra-cerebral pathology or epilepsy
* MRI findings indicative of intra-cerebral pathology
* significant post-traumatic encephalopathy from head trauma sustained at SCI or cognitive impairment indicative of traumatic brain injury
* current diagnosis of DSM-IV Axis I disorder
* inability to meet the MRI screening requirements (including, but not limited to, the presence of a pacemaker or other electronic devices, prosthesis, artificial limb or joint, shunt, some metal rods, some tattoos, or moderate to severe claustrophobia or anxiety)
18 Years
70 Years
ALL
Yes
Sponsors
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University of Miami
OTHER
US Department of Veterans Affairs
FED
Responsible Party
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Principal Investigators
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Eva G. Widerstrom-Noga, DDS PhD
Role: PRINCIPAL_INVESTIGATOR
VA Medical Center, Miami
Locations
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VA Medical Center, Miami
Miami, Florida, United States
Countries
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References
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Eaton MJ, Widerstrom-Noga E, Wolfe SQ. Subarachnoid Transplant of the Human Neuronal hNT2.19 Serotonergic Cell Line Attenuates Behavioral Hypersensitivity without Affecting Motor Dysfunction after Severe Contusive Spinal Cord Injury. Neurol Res Int. 2011;2011:891605. doi: 10.1155/2011/891605. Epub 2011 Jun 1.
Widerstrom-Noga E, Pattany PM, Cruz-Almeida Y, Felix ER, Perez S, Cardenas DD, Martinez-Arizala A. Metabolite concentrations in the anterior cingulate cortex predict high neuropathic pain impact after spinal cord injury. Pain. 2013 Feb;154(2):204-212. doi: 10.1016/j.pain.2012.07.022. Epub 2012 Nov 8.
Cruz-Almeida Y, Felix ER, Martinez-Arizala A, Widerstrom-Noga EG. Decreased spinothalamic and dorsal column medial lemniscus-mediated function is associated with neuropathic pain after spinal cord injury. J Neurotrauma. 2012 Nov 20;29(17):2706-15. doi: 10.1089/neu.2012.2343. Epub 2012 Aug 27.
Felix ER, Widerstrom-Noga EG. Reliability and validity of quantitative sensory testing in persons with spinal cord injury and neuropathic pain. J Rehabil Res Dev. 2009;46(1):69-83.
Cruz-Almeida Y, Alameda G, Widerstrom-Noga EG. Differentiation between pain-related interference and interference caused by the functional impairments of spinal cord injury. Spinal Cord. 2009 May;47(5):390-5. doi: 10.1038/sc.2008.150. Epub 2008 Nov 25.
Widerstrom-Noga EG, Cruz-Almeida Y, Felix ER, Adcock JP. Relationship between pain characteristics and pain adaptation type in persons with SCI. J Rehabil Res Dev. 2009;46(1):43-56.
Other Identifiers
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B5023-R
Identifier Type: -
Identifier Source: org_study_id
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