Modulation of Painful Perception

Healthy Clinical Trial

— MODOU  

Official title:

Modulation of Painful Perception

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02528578
• Other study ID #: 1208141
• Secondary ID: 2012-A01232-41
• Status: Completed
• Phase: N/A
• First received: August 17, 2015
• Last updated: September 25, 2017
• Start date: June 2013
• Est. completion date: November 2015

Study information

• Verified date: September 2016
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
France	Hospices Civils de LYON	Lyon
France	CHU de SAINT-ETIENNE	Saint-etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intensity of the perceived pain assessed by the volunteer by a analog scale (VAS) at each thermal stimulation.		Day 0
Secondary	blood-oxygen-level dependent (MRI)		Day 0