The Neurobiology of Expectancy and Pain Perception

A Brain Imaging Study of the Analgesic Effect of Lidocaine and the Hyperalgesic Effect of Capsaicin

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Device: Heat pain applied using TSA or CHEPS

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Charlestown, Massachusetts, United States, 02129
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Subjective Response to Pain (0-20 Visual Analogue Scale)	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.	Weeks 1-3
fMRI Signal Changes in the Dorsal Anterior Cingulate Cortex	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).	Week 4

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Investigators: Principal Investigator: Jian Kong, MD,eq/MS/MPH, Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: February 24, 2012
• First Submitted That Met QC Criteria: April 9, 2012
• First Posted (Estimate): April 11, 2012

Study Record Updates

• Last Update Posted (Actual): October 13, 2017
• Last Update Submitted That Met QC Criteria: September 12, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 2011P000663

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No