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

Spinal Cord Injury Clinical Trial

— MRS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00561782
• Other study ID #: B5023-R
• Status: Completed
• Phase: N/A
• First received: November 19, 2007
• Last updated: September 16, 2014
• Start date: October 2007
• Est. completion date: November 2010

Study information

• Verified date: September 2014
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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)

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hyperalgesia
• Hyperalgesia, Secondary
• Hyperalgesic Sensations
• Spinal Cord Injuries
• Spinal Cord Injury

Locations

Country	Name	City	State
United States	VA Medical Center, Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
VA Office of Research and Development	University of Miami

Country where clinical trial is conducted

United States, 

References & Publications (6)

Cruz-Almeida Y, Alameda G, Widerström-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. — View Citation

Cruz-Almeida Y, Felix ER, Martinez-Arizala A, Widerström-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 — View Citation

Eaton MJ, Widerström-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. — View Citation

Felix ER, Widerström-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. — View Citation

Widerström-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):204-12. doi: — View Citation

Widerström-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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No