Acute Pain Memory Among Former Burned: Exploration of fMRI.

Not Applicable

Terminated

• Conditions: Magnetic Resonance Imaging; Neuronal Activity
• Interventions: Other: fMRI

• Registration Number: NCT03224975
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

Study Timeline

• Study First Submitted: 2017-07-13
• Study First Submitted QC: 2017-07-18
• Study First Posted: 2017-07-21
• Study Start: 2018-02-13
• Primary Completion: 2019-11-25
• Study Completion: 2019-11-25
• Status Verified: 2020-04
• Last Update Submitted: 2020-09-16
• Last Update Posted: 2020-09-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	fMRI	Healthy volunteers (control group) will have fMRI.
patients	fMRI	Patient who was burned will have fMRI.

Primary Outcome Measures

Name	Time	Method
BOLD (blood-oxygen-level dependent) signal between control test.	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	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	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 painful memories	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

Name	Time	Method
BOLD (blood-oxygen-level dependent) signal between patients for every conditions	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 control group for every conditions	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.

Trial Locations

Locations (1)

CHU de Saint-Etienne; 🇫🇷 Saint-Etienne, France