NCT01575106

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Jun 2012

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 24, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 11, 2012

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
4 years until next milestone

Results Posted

Study results publicly available

October 13, 2017

Completed
Last Updated

October 13, 2017

Status Verified

January 1, 2017

Enrollment Period

1.3 years

First QC Date

February 24, 2012

Results QC Date

January 6, 2017

Last Update Submit

September 12, 2017

Conditions

Pain

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (1)

Arm 1

EXPERIMENTAL

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

Interventions

Heat pain applied using TSA or CHEPSDEVICE

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)

Arm 1

Eligibility Criteria

Age21 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • a) Healthy male and female adults aged 21-50
  • b) No contraindications to fMRI scanning
  • c) Right handed

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Massachusetts General Hospital

Charlestown, Massachusetts, 02129, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Jian Kong
Organization
Massachusetts General Hospital
JKONG2@mgh.harvard.edu
617-726-7893

Study Officials

  • Jian Kong, MD,eq/MS/MPH

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 24, 2012

First Posted

April 11, 2012

Study Start

June 1, 2012

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

October 13, 2017

Results First Posted

October 13, 2017

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)