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
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, see Learn About Clinical Studies.

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 September 30, 2014