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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
Results First Submitted: January 6, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition: Pain
Intervention: Device: Heat pain applied using TSA or CHEPS

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Heat Pain

There is only one cohort in this study. All subjects receive the same intervention, the application of heat pain using TSA or CHEPS.

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)


Participant Flow:   Overall Study
    Heat Pain
STARTED   38 
COMPLETED   24 
NOT COMPLETED   14 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Heat Pain

There is only one cohort in this study. All subjects receive the same intervention, the application of heat pain using TSA or CHEPS.

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)


Baseline Measures
   Heat Pain 
Overall Participants Analyzed 
[Units: Participants]
 24 
Age 
[Units: Years]
Mean (Standard Deviation)
 26.5  (6.7) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      11  45.8% 
Male      13  54.2% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Subjective Response to Pain (0-20 Visual Analogue Scale)   [ Time Frame: Weeks 1-3 ]

2.  Primary:   fMRI Signal Changes in the Dorsal Anterior Cingulate Cortex   [ Time Frame: Week 4 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jian Kong
Organization: Massachusetts General Hospital
phone: 617-726-7893
e-mail: JKONG2@mgh.harvard.edu



Responsible Party: Jian Kong, 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