Skip to main content
OpenTrials
Completed

NCT Number: NCT00561782

MR Spectroscopy 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.

Completed

Looking for future studies?

Notify Me

Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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
  • 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)

Treatment and study plan

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

Sponsors and collaborators

Lead sponsor

US Department of Veterans Affairs

Fed

Collaborators

  • University of Miami

Registry information

Official study title

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

Acronym: MRS

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Nov 21, 2007
Registry last updated
Sep 17, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.