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

This study is not yet open for participant recruitment.
Verified June 2017 by Centre Hospitalier Universitaire de Saint Etienne
Sponsor:
ClinicalTrials.gov Identifier:
NCT03224975
First Posted: July 21, 2017
Last Update Posted: October 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne
  Purpose
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.

Condition Intervention
Magnetic Resonance Imaging Neuronal Activity Other: fMRI

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Two groups: 20 patients and 20 healthy volunteers
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Acute Pain Memory Among Former Burned: Exploration of Functional Magnetic Resonance Imaging (fMRI).

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:
  • 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.

  • 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.

  • 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.

  • 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.


Secondary Outcome Measures:
  • 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.

  • 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.


Estimated Enrollment: 40
Anticipated Study Start Date: December 2017
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: October 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: functional Magnetic Resonance Imaging (fMRI)

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 14 and 20 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03224975


Contacts
Contact: Jean-Claude GETENET, MD (0)477828882 ext +33 j.claude.getenet@chu-st-etienne.fr
Contact: Marie PEURIERE, CRA (0)477829272 ext +33 Marie.Peuriere@chu-st-etienne.fr

Locations
France
CHU de Saint-Etienne Not yet recruiting
Saint-Etienne, France, 42055
Principal Investigator: Jean-Claude GETENET, MD         
Sub-Investigator: Bernard LAURENT, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
Principal Investigator: Jean-Claude GETENET, MD CHU SAINT-ETIENNE
  More Information

Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT03224975     History of Changes
Other Study ID Numbers: 1708030
ID-RCB ( Other Identifier: 2017-A00918-45 )
First Submitted: July 13, 2017
First Posted: July 21, 2017
Last Update Posted: October 30, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Pain
Brain responses
Neuroimaging
fMRI
Burn
Memory

Additional relevant MeSH terms:
Acute Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms