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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01242540
Other study ID # PRO10020252
Secondary ID
Status Completed
Phase N/A
First received November 15, 2010
Last updated June 22, 2017
Start date November 2010
Est. completion date October 2016

Study information

Verified date June 2017
Source University of Pittsburgh
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 15
Est. completion date October 2016
Est. primary completion date June 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States University of Pittsburgh Pittsburgh Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

Peyron R, Laurent B, García-Larrea L. Functional imaging of brain responses to pain. A review and meta-analysis (2000). Neurophysiol Clin. 2000 Oct;30(5):263-88. Review. — View Citation

Seifert F, Bschorer K, De Col R, Filitz J, Peltz E, Koppert W, Maihöfner 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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary To determine the areas of brain activity from a 2 minute long painful stimulation After a 2 minute long painful stimulation
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