MR Spectroscopy as a Diagnostic and Outcome Measure in Pain and SCI (MRS)

This study has been completed.
Sponsor:
Collaborator:
University of Miami
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00561782
First received: November 19, 2007
Last updated: September 16, 2014
Last verified: September 2014

November 19, 2007
September 16, 2014
October 2007
November 2010   (final data collection date for primary outcome measure)
Using MR Spectroscopy to measure the concentration of N-acetyl aspartate, glutamate/glutamine, and myo-inositol in the areas of the brain thought to process pain. [ Time Frame: Two measures at intervals of 2 to 4 weeks ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00561782 on ClinicalTrials.gov Archive Site
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MR Spectroscopy as a Diagnostic and Outcome Measure in Pain and SCI
MR Spectroscopy (MRS) as a Diagnostic and Outcome Measure in Pain and SCI

The goal of this study is to compare the changes that occur in sensation and chemical properties of the brain following SCI between individuals that experience chronic pain and those that do not, and between those with SCI and the able-bodied.

This study investigates the differences in certain neurochemicals present in areas of the brain linked to pain processing in people with SCI and neuropathic pain, in people with SCI but no pain, and in able-bodied persons. We will also investigate the relationship between these concentrations of neurochemicals and different aspects of chronic neuropathic pain, including the intensity of pain, quality of life issues, sensitivity changes in areas of the body that are both painful and non-painful, and neurological status.

Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

Both spinal cord injured (85) and able-bodied (25) subjects will be studied. Of those with spinal cord injury, 60 will be those who experience central neuropathic pain and 25 will not. An additional 25 people who screen positive for mild to moderate TBI symptoms and pain attributable to TBI will be studied.

  • Spinal Cord Injury
  • Hyperalgesia, Secondary
  • Hyperalgesic Sensations
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  • Group 1
    Spinal cord injured with chronic central neuropathic pain.
  • Group 2
    Spinal cord injured without chronic central neuropathic pain.
  • Group 3
    Able-bodied without history of chronic pain of any type
  • Group 4
    Traumatically Brain Injured with a history of pain that onset after their TBI

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
94
November 2010
November 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  1. SCI and neuropathic pain:

    • 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:

  • current pregnancy or women who are contemplating pregnancy
  • 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)
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00561782
B5023-R
No
Department of Veterans Affairs
Department of Veterans Affairs
University of Miami
Principal Investigator: Eva G. Widerstrom-Noga, DDS PhD VA Medical Center, Miami
Department of Veterans Affairs
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP