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

Primary Purpose

Magnetic Resonance Imaging, Neuronal Activity

Status
Terminated
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
fMRI
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Magnetic Resonance Imaging focused on measuring Pain, Brain responses, Neuroimaging, fMRI, Burn, Memory

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHU de Saint-Etienne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

patients

control group

Arm Description

Patient who was burned will have fMRI.

Healthy volunteers (control group) will have fMRI.

Outcomes

Primary Outcome Measures

BOLD (blood-oxygen-level dependent) signal between painful memories
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
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
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.
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
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
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.

Full Information

First Posted
July 13, 2017
Last Updated
September 16, 2020
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
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1. Study Identification

Unique Protocol Identification Number
NCT03224975
Brief Title
Acute Pain Memory Among Former Burned: Exploration of fMRI.
Acronym
EXPLO-DMA
Official Title
Acute Pain Memory Among Former Burned: Exploration of Functional Magnetic Resonance Imaging (fMRI).
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Terminated
Why Stopped
failure to recruit
Study Start Date
February 13, 2018 (Actual)
Primary Completion Date
November 25, 2019 (Actual)
Study Completion Date
November 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Magnetic Resonance Imaging, Neuronal Activity
Keywords
Pain, Brain responses, Neuroimaging, fMRI, Burn, Memory

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Two groups: 20 patients and 20 healthy volunteers
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
patients
Arm Type
Experimental
Arm Description
Patient who was burned will have fMRI.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Healthy volunteers (control group) will have fMRI.
Intervention Type
Other
Intervention Name(s)
fMRI
Other Intervention Name(s)
functional Magnetic Resonance Imaging (fMRI)
Intervention Description
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.
Primary Outcome Measure Information:
Title
BOLD (blood-oxygen-level dependent) signal between painful memories
Description
Correlation between BOLD measured by functional Magnetic Resonance Imaging (fMRI) and every conditions: painful memories, emotional memories not painful, neutral memories and control test.
Time Frame
Months 3
Title
BOLD (blood-oxygen-level dependent) signal between emotional memories not painful
Description
Correlation between BOLD measured by functional Magnetic Resonance Imaging (fMRI) and every conditions: painful memories, emotional memories not painful, neutral memories and control test.
Time Frame
Months 3
Title
BOLD (blood-oxygen-level dependent) signal between neutral memories
Description
Correlation between BOLD measured by functional Magnetic Resonance Imaging (fMRI) and every conditions: painful memories, emotional memories not painful, neutral memories and control test.
Time Frame
Months 3
Title
BOLD (blood-oxygen-level dependent) signal between control test.
Description
Correlation between BOLD measured by functional Magnetic Resonance Imaging (fMRI) and every conditions: painful memories, emotional memories not painful, neutral memories and control test.
Time Frame
Months 3
Secondary Outcome Measure Information:
Title
BOLD (blood-oxygen-level dependent) signal between control group for every conditions
Description
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.
Time Frame
Months 3
Title
BOLD (blood-oxygen-level dependent) signal between patients for every conditions
Description
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.
Time Frame
Months 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Claude GETENET, MD
Organizational Affiliation
CHU SAINT-ETIENNE
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU de Saint-Etienne
City
Saint-Etienne
ZIP/Postal Code
42055
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Acute Pain Memory Among Former Burned: Exploration of fMRI.

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