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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT03224975
Other study ID # 1708030
Secondary ID ID-RCB
Status Terminated
Phase N/A
First received
Last updated
Start date February 13, 2018
Est. completion date November 25, 2019

Study information

Verified date April 2020
Source Centre Hospitalier Universitaire de Saint Etienne
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 24
Est. completion date November 25, 2019
Est. primary completion date November 25, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
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 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. Months 3
Primary 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. Months 3
Primary 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. Months 3
Primary 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. Months 3
Secondary 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. Months 3
Secondary 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. Months 3
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