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CompletedNCT00561782MRSUpdated Sep 17, 2014

MR Spectroscopy as a Diagnostic and Outcome Measure in Pain and SCI

An observational study in Spinal Cord Injury, Hyperalgesia, Secondary and Hyperalgesic Sensations, sponsored by US Department of Veterans Affairs. Completed at 1 site in United States. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-09-17.

Sponsored by US Department of Veterans Affairs · Observational

Study type
Observational
Model
Case-control
Time perspective
Prospective
Enrollment
94
Ages
18 Years to 70 Years
Sex
All
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Study summary

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.

Read the detailed description

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.

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Conditions studied

  • Spinal Cord Injury
  • Hyperalgesia, Secondary
  • Hyperalgesic Sensations

Keywords

  • Spinal Cord Injury Pain
  • Chronic Neuropathic Pain
  • SCI Pain
  • Pain, Chronic Neuropathic
  • Spectroscopy, Magnetic Resonance
  • MRS
  • Traumatic Brain Injury Pain
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In context

Spinal Cord Injuries

1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.

This study's enrollment of 94 is above the median of 60 across 323 observational studies indexed under Spinal Cord Injuries.

Browse Spinal Cord Injuries studies →

Lead sponsor

US Department of Veterans Affairs is the lead sponsor of 658 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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.

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

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)
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Study design

Observational model
Case-control
Time perspective
Prospective
Enrollment
94 participants (actual)

Groups and cohorts

  • 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

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What researchers measure

Primary outcomes

  1. 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

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Study locations

1 site
  • VA Medical Center, Miami
    Miami, Florida 33125, United States
08

References and documents

Publications

  • 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. PubMed 21799949 ↗
  • 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. PubMed 23141478 ↗
  • 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. PubMed 22845918 ↗
  • 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. PubMed 19533521 ↗
  • 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. PubMed 19030010 ↗
  • 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. PubMed 19533519 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 17, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00561782
Lead sponsor
US Department of Veterans Affairs
Collaborators
University of Miami
Responsible party
Sponsor
First posted
Nov 21, 2007
Start date
Oct 2007
Primary completion
Nov 2010
Completion
Nov 2010
Last update
Sep 17, 2014

Study contacts

Eva G. Widerstrom-Noga, DDS PhD
principal investigator · VA Medical Center, Miami

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2014. You cannot join it, but the record below documents what was studied.

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