The Neurobiology of Expectancy and Pain Perception

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jian Kong, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01575106
First received: February 24, 2012
Last updated: January 17, 2014
Last verified: January 2014
  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: Single Blind (Subject)

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • fMRI signal changes [ Time Frame: One day ] [ Designated as safety issue: No ]
    fMRI signal changes during heat pain


Secondary Outcome Measures:
  • Subjective response to pain [ Time Frame: 1to 3 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: June 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: June 2015 (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.
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

Ages Eligible for Study:   21 Years to 50 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01575106

Locations
United States, Massachusetts
Massachusetts General Hospital
Charlestown, Massachusetts, United States, 02129
Sponsors and Collaborators
Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Jian Kong, Assistant Professor, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01575106     History of Changes
Other Study ID Numbers: 2011P000663
Study First Received: February 24, 2012
Last Updated: January 17, 2014
Health Authority: United States: Institutional Review Board

ClinicalTrials.gov processed this record on April 23, 2014