Acute Pain Memory Among Former Burned: Exploration of fMRI. (EXPLO-DMA)

September 16, 2020 updated by: Centre Hospitalier Universitaire de Saint Etienne

Acute Pain Memory Among Former Burned: Exploration of Functional Magnetic Resonance Imaging (fMRI).

Pain is complex phenomenon misunderstood in spite of medical progress and neurosciences. That's why the relief of chronic pain is only partial for a lot of infection as arthrosis, chronic back pain, headaches or neuropathic pain. Certain situations bring to relive pain sensation. Investigators were interested to former burned. They wonder about somatic memory and unconscious of acute.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

It is a comparative and monocentric study. There are two groups. On the one hand, there is the former burned and, on the other hand, healthy volunteers. While they thought to painful memory or not, functional Magnetic Resonance Imaging (fMRI) will be performed. Then, investigators compare two functional Magnetic Resonance Imaging (fMRI).

Main objective of this study is link up between brain activity by functional Magnetic Resonance Imaging (fMRI) and acute pain memory.

Study Type

Interventional

Enrollment (Actual)

24

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
      • Saint-Etienne, France, 42055
        • 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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

For control group:

  • Affiliated or entitled to a social security
  • Have signed consent before their participation in the study
  • Adult women and men french and is right handed
  • Vision and hearing normal or corrected

For former burned:

  • Affiliated or entitled to a social security
  • Have signed consent before their participation in the study
  • Adult women and men french and is right handed
  • Vision and hearing normal or corrected
  • Localized burn at the hand or feet onset between 12 and 24 years
  • Not sequelae painful at the inclusion
  • Scope and depth of the burn according to classifications CIM 10

Exclusion Criteria:

For control group:

  • Any contraindications to pass an fMRI test
  • Neuropathic pains and psychiatric disorders
  • Medical history of head injuries
  • Burn presence

For former burned:

  • Any contraindications to pass an fMRI test
  • Neuropathic pains and psychiatric disorders
  • Medical history of head injuries

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: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: patients
Patient who was burned will have fMRI.
Other: fMRI
During fMRI, patients and control group will have to thought to seven painful memories, seven emotional memories not painful, seven neutral memories. At every memory there is control test. It is to count backwards.
Other Names:
  • functional Magnetic Resonance Imaging (fMRI)
Active Comparator: control group
Healthy volunteers (control group) will have fMRI.
Other: fMRI
During fMRI, patients and control group will have to thought to seven painful memories, seven emotional memories not painful, seven neutral memories. At every memory there is control test. It is to count backwards.
Other Names:
  • functional Magnetic Resonance Imaging (fMRI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BOLD (blood-oxygen-level dependent) signal between painful memories
Time Frame: Months 3
Correlation between BOLD measured by functional Magnetic Resonance Imaging (fMRI) and every conditions: painful memories, emotional memories not painful, neutral memories and control test.
Months 3
BOLD (blood-oxygen-level dependent) signal between emotional memories not painful
Time Frame: Months 3
Correlation between BOLD measured by functional Magnetic Resonance Imaging (fMRI) and every conditions: painful memories, emotional memories not painful, neutral memories and control test.
Months 3
BOLD (blood-oxygen-level dependent) signal between neutral memories
Time Frame: Months 3
Correlation between BOLD measured by functional Magnetic Resonance Imaging (fMRI) and every conditions: painful memories, emotional memories not painful, neutral memories and control test.
Months 3
BOLD (blood-oxygen-level dependent) signal between control test.
Time Frame: Months 3
Correlation between BOLD measured by functional Magnetic Resonance Imaging (fMRI) and every conditions: painful memories, emotional memories not painful, neutral memories and control test.
Months 3

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BOLD (blood-oxygen-level dependent) signal between control group for every conditions
Time Frame: Months 3
Correlation between BOLD measured by functional Magnetic Resonance Imaging (fMRI) and groups for every conditions: painful memories, emotional memories not painful, neutral memories and control test.
Months 3
BOLD (blood-oxygen-level dependent) signal between patients for every conditions
Time Frame: Months 3
Correlation between BOLD measured by functional Magnetic Resonance Imaging (fMRI) and groups for every conditions: painful memories, emotional memories not painful, neutral memories and control test.
Months 3

Collaborators and Investigators

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

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Jean-Claude GETENET, MD, CHU 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)

February 13, 2018

Primary Completion (Actual)

November 25, 2019

Study Completion (Actual)

November 25, 2019

Study Registration Dates

First Submitted

July 13, 2017

First Submitted That Met QC Criteria

July 18, 2017

First Posted (Actual)

July 21, 2017

Study Record Updates

Last Update Posted (Actual)

September 17, 2020

Last Update Submitted That Met QC Criteria

September 16, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1708030
  • ID-RCB (Other Identifier: 2023-A01937-38)

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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