Spinal Cord InjuryMRSNCT00561782
MR Spectroscopy as a Diagnostic and Outcome Measure in Pain and SCI
An observational study of Spinal Cord Injury and Hyperalgesia, Secondary, run by US Department of Veterans Affairs at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury, Hyperalgesia, Secondary, Hyperalgesic Sensations
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2007to Nov 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Show all 15Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: MR Spectroscopy (MRS) 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.
Read the 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.
- Keywords
- Spinal Cord Injury Pain, Chronic Neuropathic Pain, SCI Pain, Pain, Chronic Neuropathic, Spectroscopy, Magnetic Resonance, MRS, Traumatic Brain Injury Pain
- Medical subject headings
- Spinal Cord Injuries, Hyperalgesia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Two measures at intervals of 2 to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2007 (estimated)
- Study startOct 2007
- Primary completionNov 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Collaborators
- University of Miami
- Responsible party
- Sponsor
- Investigators
- Eva G. Widerstrom-Noga, DDS PhD, Principal investigator, VA Medical Center, Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00561782
- Sponsor's protocol ID
- B5023-R
- Acronym
- MRS
- Status last verified
- Sep 2014
- First submitted
- 19 Nov 2007
- Last updated
- 17 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21799949Widerstrom-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.
PubMed 23141478Cruz-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.
PubMed 22845918Felix 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.
PubMed 19533521Cruz-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.
PubMed 19030010Widerstrom-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.
PubMed 19533519
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MR Spectroscopy (MRS) as a Diagnostic and Outcome Measure in Pain and SCI
- ClinicalTrials.gov ID
- NCT00561782
- Acronym / sponsor ID
- MRS / B5023-R
- Keywords
- Spinal Cord Injury Pain, Chronic Neuropathic Pain, SCI Pain, Pain, Chronic Neuropathic, Spectroscopy, Magnetic Resonance, MRS, Traumatic Brain Injury Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Collaborators
- University of Miami
- Study start
- Oct 2007
- Primary completion
- Nov 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 21 Nov 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (15 listed)
- SCI and neuropathic pain:
- SCI and no neuropathic pain:
- Able-bodied control subjects:
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2014.
- Background: PubMed 21799949Eaton 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.
- Results publication: PubMed 23141478Widerstrom-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.
- Results publication: PubMed 22845918Cruz-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.
- Results publication: PubMed 19533521Felix 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.
- Results publication: PubMed 19030010Cruz-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.
- Results publication: PubMed 19533519Widerstrom-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eva G. Widerstrom-Noga, DDS PhD principal investigator
VA Medical Center, Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injury and Hyperalgesia, Secondary, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00561782, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2014.