Modulation of Painful Perception (MODOU)

September 25, 2017 updated by: Centre Hospitalier Universitaire de Saint Etienne

The objective of the study is to evaluate in healthy volunteers, the influence of empathy on pain perception.

It is widely accepted in the clinical management that the feeling of listening to the patients' pain would have a favorable influence on the pain, and conversely, the lack of listening would be aggravating.

In this study, the volunteer will receive painful thermal stimuli in empathetic context (l, empathetic or non-empathetic) Two situations will oppose, one where the examiner neglect or minimize the suffering of the voluntary and the other or the contrary, the subject will receive empathy.

The first part of the project is to verify that the pain is influenced by the empathetic context. The second part will be conducted functional MRI, which should isolate the brain regions affected by other people's empathy for pain.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

74

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Lyon, France, 69500
        • Hospices Civils de Lyon
      • Saint-etienne, France, 42000
        • CHU de Saint-Etienne

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Right handed

Exclusion Criteria:

  • Pregnant or lactating women,
  • Against-indications to MRI
  • Drug intake of less than 12 hours,
  • Neurological history or deficits, psychiatric, auditory or visual.
  • Decline to participate

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: healthy volunteers
Device: thermal stimulation delivered by a thermode.
Empathetic context (neutral, empathetic, non-empathetic) when thermal stimulation
Other: functional MRI
MRI realised with thermal stimulations and empathetic context (neutral, empathetic, non-empathetic) when thermal stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intensity of the perceived pain assessed by the volunteer by a analog scale (VAS) at each thermal stimulation.
Time Frame: Day 0
Day 0

Secondary Outcome Measures

Outcome Measure
Time Frame
blood-oxygen-level dependent (MRI)
Time Frame: Day 0
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2013

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

August 17, 2015

First Submitted That Met QC Criteria

August 18, 2015

First Posted (Estimate)

August 19, 2015

Study Record Updates

Last Update Posted (Actual)

September 26, 2017

Last Update Submitted That Met QC Criteria

September 25, 2017

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 1208141
  • 2012-A01232-41 (Other Identifier: AFSSAPS)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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