Brain Activation During Accommodation to Painful Stimulation With FMRI
| Tracking Information | |||||
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| First Received Date ICMJE | November 15, 2010 | ||||
| Last Updated Date | August 23, 2011 | ||||
| Start Date ICMJE | November 2010 | ||||
| Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To determine the areas of brain activity from a 2 minute long painful stimulation [ Time Frame: After a 2 minute long painful stimulation ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01242540 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Brain Activation During Accommodation to Painful Stimulation With FMRI | ||||
| Official Title ICMJE | Brain Activation During Accommodation to Painful Stimulation With Functional Imaging of Pain | ||||
| Brief Summary | Blood oxygen level dependant (BOLD) functional magnetic resonance imaging (FMRI) investigations of pain have provided substantial insight into the workings of the human brain. To date, however, the vast majority of studies have dealt with short painful stimulations. This work will expand the investigators knowledge of how longer stimulations are processed by comparing the activation pattern from a two minute painful stimulation with that of an 30-second painful stimulus. The investigators hypothesis that accommodation to the longer stimulation will be evident by either decreases in signal intensity in brain areas known to process pain, or by increasing activity in brain areas thought to be responsible for the modulation of painful perception. |
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| Detailed Description | Background: Over the past 14 years, BOLD FMRI studies have non-invasively shown that pain activates a matrix of areas, but that this activation decays during stimulation, possibly reflecting the body's ability to "accommodate" to the stimulation. The majority of these use short applications of pain lasting 1 to 30 seconds. However, investigators are now using stimulations much longer than the periods that were typical a few years ago. The effect of signal decay on the activation maps generated by these longer tasks is not known. Because the signal change in many of the subcortical areas involved in pain processing is low, errors in analysis due to neglecting the signal decay may induce significant artifact. Materials and Methods: Using transcutaneous electrical nerve stimulation, 20 healthy volunteers will experience two different painful stimulations: a repeating 30-second long stimulation and a constant 2 minute stimulation. The brain activity for each will be determined and compared. In addition, the signal decay during each painful stimulation will be quantified and compared. Significance: Investigators are using longer stimulations periods in an attempt to understand how the brain processes "real- life" pain instead of the artificial on-off pattern of earlier studies. However, significant attention has not been paid to the possible effect of accommodation on the stimulus and how this may impact the activity pattern found. In addition, proof of activation of pain-control areas like the periaquaductal gray while inverse changes are occurring in pain-perceiving areas has not been sought. This study will address both of these issues with a single BOLD FMRI experiment. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Cross-Sectional |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Subjects will come from the general surrounding community. |
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| Condition ICMJE | Pain | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 20 | ||||
| Estimated Completion Date | October 2011 | ||||
| Primary Completion Date | June 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 50 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01242540 | ||||
| Other Study ID Numbers ICMJE | PRO10020252 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Jim Ibinson, University of Pittsburgh | ||||
| Study Sponsor ICMJE | University of Pittsburgh | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Pittsburgh | ||||
| Verification Date | August 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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