NCT01242540

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2010

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2010

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 15, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 17, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
5.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2016

Completed
Last Updated

June 26, 2017

Status Verified

June 1, 2017

Enrollment Period

7 months

First QC Date

November 15, 2010

Last Update Submit

June 22, 2017

Conditions

Keywords

PainFunctional Magnetic Resonance Imaging

Outcome Measures

Primary Outcomes (1)

  • To determine the areas of brain activity from a 2 minute long painful stimulation

    After a 2 minute long painful stimulation

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Subjects will come from the general surrounding community.

You may qualify if:

  • Age 18 to 50
  • Right-handed
  • Male or female
  • Healthy individuals not taking any medication.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15213, United States

Location

Related 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. doi: 10.1097/00000542-200410000-00022.

    PMID: 15448530BACKGROUND
  • 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.

    PMID: 11126640BACKGROUND
  • 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.

    PMID: 11923440BACKGROUND
  • 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.

    PMID: 19439594BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • James W Ibinson, MD, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Instructor

Study Record Dates

First Submitted

November 15, 2010

First Posted

November 17, 2010

Study Start

November 1, 2010

Primary Completion

June 1, 2011

Study Completion

October 1, 2016

Last Updated

June 26, 2017

Record last verified: 2017-06

Locations