Modulation of Painful Perception (MODOU)

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: Healthy
• Intervention / Treatment: Device: thermal stimulation delivered by a thermode.; Other: functional MRI

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

1

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.	Day 0

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Study record dates

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: healthy volunteers
• 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