Brain Activation During Accommodation to Painful Stimulation With FMRI

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by University of Pittsburgh.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Jim Ibinson, University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01242540
First received: November 15, 2010
Last updated: August 23, 2011
Last verified: August 2011

November 15, 2010
August 23, 2011
November 2010
June 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01242540 on ClinicalTrials.gov Archive Site
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Brain Activation During Accommodation to Painful Stimulation With FMRI
Brain Activation During Accommodation to Painful Stimulation With Functional Imaging of Pain

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Cross-Sectional
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Probability Sample

Subjects will come from the general surrounding community.

Pain
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
October 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01242540
PRO10020252
Yes
Jim Ibinson, University of Pittsburgh
University of Pittsburgh
Not Provided
Principal Investigator: James W Ibinson, MD, PhD University of Pittsburgh
University of Pittsburgh
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP