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The Neurobiology of Expectancy and Pain Perception

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01575106
First Posted: April 11, 2012
Last Update Posted: October 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Jian Kong, Massachusetts General Hospital
  Purpose
This study will use using fMRI (functional Magnetic Resonance Imaging) to elucidate how contextual learning/expectation relieves or aggravates pain experience in the same cohort of subjects and the same study session.

Condition Intervention
Pain Device: Heat pain applied using TSA or CHEPS

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Brain Imaging Study of the Analgesic Effect of Lidocaine and the Hyperalgesic Effect of Capsaicin

Further study details as provided by Jian Kong, Massachusetts General Hospital:

Primary Outcome Measures:
  • Subjective Response to Pain (0-20 Visual Analogue Scale) [ Time Frame: Weeks 1-3 ]
    Subjects received heat pain before and after the application of a neutral cream (told one application of neutral cream was lidocaine, one was capsaicin, and one was neutral) and rated pain intensity on a 0-20 Visual Analogue Scale (0-no pain, 20-intolerable pain). We only measure this outcome measure in session 3. The pain intensity for each cream was averaged amongst all participants for both the pre and post treatment in session 3. Subjects have up to 3 weeks to complete the 3 sessions.

  • fMRI Signal Changes in the Dorsal Anterior Cingulate Cortex [ Time Frame: Week 4 ]
    We used fMRI to investigate the signal changes associated with administration of identical pain stimuli before (pre) and after the treatment (post) with different creams in session 3. It is important to note that the subjects had multiple weeks to complete the study, but this measure was only taken during one session. The change was calculated from two time points as the value at the later time point (post treatment) minus the value at the earlier time point (pre treatment).


Enrollment: 38
Study Start Date: June 2012
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
There is only one cohort in this study. All subjects receive the same intervention, the application of heat pain using TSA or CHEPS.
Device: Heat pain applied using TSA or CHEPS
TSA-2001 Thermal Sensory Analyzer (Medoc LTD Advanced Medical Systems) or the Pathway Medoc (CHEPS model, Contact Heat-Evoked Potential Stimulator, Medoc LTD Advanced Medical Systems)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • a) Healthy male and female adults aged 21-50
  • b) No contraindications to fMRI scanning
  • c) Right handed

Exclusion Criteria:

  • a) Current or past history of major medical, neurological, or psychiatric illness
  • b) Pregnancy or breast feeding, menopause, and irregular menstrual cycles (length of cycle must be within 26 to 32 days)
  • c) Claustrophobia
  • d) History of head trauma
  • e) History of impaired elimination
  • f) Instability of responses to experimental pain (see Study Procedures Section)
  • g) Use of psychotropic drugs, hormone treatments (including hormonal birth control) within 1 year
  • h) Non-fluent speaker of English
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01575106


Locations
United States, Massachusetts
Massachusetts General Hospital
Charlestown, Massachusetts, United States, 02129
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Jian Kong, MD,eq/MS/MPH Massachusetts General Hospital
  More Information

Responsible Party: Jian Kong, Assistant Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01575106     History of Changes
Other Study ID Numbers: 2011P000663
First Submitted: February 24, 2012
First Posted: April 11, 2012
Results First Submitted: January 6, 2017
Results First Posted: October 13, 2017
Last Update Posted: October 13, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No