- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01242540
Brain Activation During Accommodation to Painful Stimulation With FMRI
Brain Activation During Accommodation to Painful Stimulation With Functional Imaging of Pain
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age 18 to 50
- Right-handed
- Male or female
- Healthy individuals not taking any medication.
Exclusion Criteria:
- Pregnancy
- Diagnosed with any treated or untreated medical or neurological conditions
- Using any prescription drugs, including antidepressants, pain medications, sedative medications, blood pressure medications, seizure medications, or antipsychotics. Oral contraceptives are permitted
- Using any over-the-counter medications including aspirin, Tylenol, or herbal supplements
- Using any illicit substances
- Contraindications to magnetic resonance imaging.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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To determine the areas of brain activity from a 2 minute long painful stimulation
Time Frame: After a 2 minute long painful stimulation
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After a 2 minute long painful stimulation
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: James W Ibinson, MD, PhD, University of Pittsburgh
Publications and helpful links
General Publications
- Ibinson JW, Small RH, Algaze A, Roberts CJ, Clark DL, Schmalbrock P. Functional magnetic resonance imaging studies of pain: an investigation of signal decay during and across sessions. Anesthesiology. 2004 Oct;101(4):960-9. doi: 10.1097/00000542-200410000-00022.
- Peyron R, Laurent B, Garcia-Larrea L. Functional imaging of brain responses to pain. A review and meta-analysis (2000). Neurophysiol Clin. 2000 Oct;30(5):263-88. doi: 10.1016/s0987-7053(00)00227-6.
- Tracey I, Ploghaus A, Gati JS, Clare S, Smith S, Menon RS, Matthews PM. Imaging attentional modulation of pain in the periaqueductal gray in humans. J Neurosci. 2002 Apr 1;22(7):2748-52. doi: 10.1523/JNEUROSCI.22-07-02748.2002.
- Seifert F, Bschorer K, De Col R, Filitz J, Peltz E, Koppert W, Maihofner C. Medial prefrontal cortex activity is predictive for hyperalgesia and pharmacological antihyperalgesia. J Neurosci. 2009 May 13;29(19):6167-75. doi: 10.1523/JNEUROSCI.4654-08.2009.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- PRO10020252
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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