NCT03224975

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 13, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 21, 2017

Completed
7 months until next milestone

Study Start

First participant enrolled

February 13, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2019

Completed
Last Updated

September 17, 2020

Status Verified

April 1, 2020

Enrollment Period

1.8 years

First QC Date

July 13, 2017

Last Update Submit

September 16, 2020

Conditions

Magnetic Resonance ImagingNeuronal Activity

Keywords

PainBrain responsesNeuroimagingfMRIBurnMemory

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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 Outcomes (2)

  • BOLD (blood-oxygen-level dependent) signal between control group for every conditions

    Months 3

  • BOLD (blood-oxygen-level dependent) signal between patients for every conditions

    Months 3

Study Arms (2)

patients

EXPERIMENTAL

Patient who was burned will have fMRI.

Other: fMRI

control group

ACTIVE COMPARATOR

Healthy volunteers (control group) will have fMRI.

Other: fMRI

Interventions

fMRIOTHER

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.

Also known as: functional Magnetic Resonance Imaging (fMRI)
control grouppatients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Scope and depth of the burn according to classifications CIM 10

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Saint-Etienne

Saint-Etienne, 42055, France

Location

MeSH Terms

Conditions

PainBurns

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsWounds and Injuries

Study Officials

  • Jean-Claude GETENET, MD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: Two groups: 20 patients and 20 healthy volunteers
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 13, 2017

First Posted

July 21, 2017

Study Start

February 13, 2018

Primary Completion

November 25, 2019

Study Completion

November 25, 2019

Last Updated

September 17, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)