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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00561782
Recruitment Status : Completed
First Posted : November 21, 2007
Last Update Posted : September 17, 2014
University of Miami
Information provided by (Responsible Party):
VA Office of Research and Development

Brief 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.

Condition or disease
Spinal Cord Injury Hyperalgesia, Secondary Hyperalgesic Sensations

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.

Study Type : Observational
Actual Enrollment : 94 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: MR Spectroscopy (MRS) as a Diagnostic and Outcome Measure in Pain and SCI
Study Start Date : October 2007
Actual Primary Completion Date : November 2010
Actual Study Completion Date : November 2010

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

Primary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   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:

  • 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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00561782

United States, Florida
VA Medical Center, Miami
Miami, Florida, United States, 33125
Sponsors and Collaborators
VA Office of Research and Development
University of Miami
Principal Investigator: Eva G. Widerstrom-Noga, DDS PhD VA Medical Center, Miami

Publications of Results:
Other Publications:
Responsible Party: VA Office of Research and Development Identifier: NCT00561782     History of Changes
Other Study ID Numbers: B5023-R
First Posted: November 21, 2007    Key Record Dates
Last Update Posted: September 17, 2014
Last Verified: September 2014

Keywords provided by VA Office of Research and Development:
Spinal Cord Injury Pain
Chronic Neuropathic Pain
SCI Pain
Pain, Chronic Neuropathic
Spectroscopy, Magnetic Resonance
Traumatic Brain Injury Pain

Additional relevant MeSH terms:
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Wounds and Injuries
Somatosensory Disorders
Sensation Disorders
Neurologic Manifestations
Signs and Symptoms