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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:
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00561782
First received: November 19, 2007
Last updated: December 14, 2010
Last verified: December 2010
History of Changes
  Purpose

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
Spinal Cord Injury
Hyperalgesia, Secondary
Hyperalgesic Sensations

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: MR Spectroscopy (MRS) as a Diagnostic and Outcome Measure in Pain and SCI

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • 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 ]

Estimated Enrollment: 110
Study Start Date: October 2007
Study Completion Date: September 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Spinal cord injured with chronic central neuropathic pain.
2
Spinal cord injured without chronic central neuropathic pain.
3
Able-bodied without history of chronic pain of any type
4
Traumatically Brain Injured with a history of pain that onset after their TBI

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.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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.

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00561782

Locations
United States, Florida
VA Medical Center, Miami
Miami, Florida, United States, 33125
Sponsors and Collaborators
Department of Veterans Affairs
University of Miami
Investigators
Principal Investigator: Eva G. Widerstrom-Noga, DDS PhD VA Medical Center, Miami
  More Information

Additional Information:
Active Studies - The Miami Project to Cure Paralysis  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Widerstrom-Noga, Eva - Principal Investigator, Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00561782     History of Changes
Other Study ID Numbers: B5023R
Study First Received: November 19, 2007
Last Updated: December 14, 2010
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
Spinal Cord Injury Pain
Chronic Neuropathic Pain
SCI Pain
Pain, Chronic Neuropathic
 Spectroscopy, Magnetic Resonance
MRS
Traumatic Brain Injury Pain

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

ClinicalTrials.gov processed this record on May 23, 2013