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

NCT ID: NCT00561782

Last Updated: 2014-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

94 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-10-31

Study Completion Date

2010-11-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Spinal Cord Injury Hyperalgesia, Secondary Hyperalgesic Sensations

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Spinal cord injured with chronic central neuropathic pain.

No interventions assigned to this group

Group 2

Spinal cord injured without chronic central neuropathic pain.

No interventions assigned to this group

Group 3

Able-bodied without history of chronic pain of any type

No interventions assigned to this group

Group 4

Traumatically Brain Injured with a history of pain that onset after their TBI

No interventions assigned to this group

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Miami

OTHER

Sponsor Role collaborator

US Department of Veterans Affairs

FED

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eva G. Widerstrom-Noga, DDS PhD

Role: PRINCIPAL_INVESTIGATOR

VA Medical Center, Miami

Locations

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VA Medical Center, Miami

Miami, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 21799949 (View on PubMed)

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.

Reference Type RESULT
PMID: 23141478 (View on PubMed)

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.

Reference Type RESULT
PMID: 22845918 (View on PubMed)

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.

Reference Type RESULT
PMID: 19533521 (View on PubMed)

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.

Reference Type RESULT
PMID: 19030010 (View on PubMed)

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.

Reference Type RESULT
PMID: 19533519 (View on PubMed)

Other Identifiers

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B5023-R

Identifier Type: -

Identifier Source: org_study_id

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