The Neurobiology of Expectancy and Pain Perception

NCT ID: NCT01575106

Last Updated: 2017-10-13

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-06-30

Study Completion Date

2013-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Heat pain applied using TSA or CHEPS

Intervention Type DEVICE

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)

Interventions

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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)

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

21 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Massachusetts General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jian Kong

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jian Kong, MD,eq/MS/MPH

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

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Massachusetts General Hospital

Charlestown, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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2011P000663

Identifier Type: -

Identifier Source: org_study_id