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

NCT00561782 | Completed

• 1 other identifier: B5023-R
• Study Type: observational
• Target: 94
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

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.

  Two measures at intervals of 2 to 4 weeks

Study Arms (4)

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• US Department of Veterans Affairs: lead
• University of Miami: collaborator

Study Sites (1)

VA Medical Center, Miami

Miami, Florida, 33125, United States

Location

Related Publications (6)

• 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.

  PMID: 21799949 BACKGROUND

• 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.

  PMID: 23141478 RESULT

• 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.

  PMID: 22845918 RESULT

• 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.

  PMID: 19533521 RESULT

• 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.

  PMID: 19030010 RESULT

• 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.

  PMID: 19533519 RESULT

MeSH Terms

Conditions

Spinal Cord Injuries; Hyperalgesia; Pain

Condition Hierarchy (Ancestors)

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; Pathological Conditions, Signs and Symptoms

Study Officials

• Eva G. Widerstrom-Noga, DDS PhD

  VA Medical Center, Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2007
• First Posted: November 21, 2007
• Study Start: October 1, 2007
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: September 17, 2014

Record last verified: 2014-09

Locations

US (1)