Magnetic Resonance ImagingEXPLO-DMANCT03224975
Acute Pain Memory Among Former Burned: Exploration of fMRI.
A study testing fMRI in people with Magnetic Resonance Imaging and Neuronal Activity, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Magnetic Resonance Imaging, Neuronal Activity
- What is being tested?
- fMRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- 13 Feb 2018to 25 Nov 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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:
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- 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
Who cannot join
- 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:
Show all 9Show fewer
- Any contraindications to pass an fMRI test
- Neuropathic pains and psychiatric disorders
- Medical history of head injuries
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Acute Pain Memory Among Former Burned: Exploration of Functional Magnetic Resonance Imaging (fMRI).
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.
Read the 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.
- Conditions
- Magnetic Resonance Imaging, Neuronal Activity
- Being tested
- fMRI
- Keywords
- Pain, Brain responses, Neuroimaging, fMRI, Burn, Memory
- Medical subject headings
- Pain, Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fMRIOther
Also called functional Magnetic Resonance Imaging (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.
| Study group | Role | What they receive |
|---|---|---|
| patients | Experimental | Patient who was burned will have fMRI. Receives: Other: fMRI |
| control group | Active comparator | Healthy volunteers (control group) will have fMRI. Receives: Other: fMRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Months 3
Secondary outcomes (2)
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.
Measured: Months 3
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.
Measured: Months 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2017
- Study start13 Feb 2018
- Primary completion25 Nov 2019
- Study completion25 Nov 2019
Why it stopped: failure to recruit
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Magnetic Resonance ImagingStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two groups: 20 patients and 20 healthy volunteers
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Claude GETENET, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03224975
- Sponsor's protocol ID
- 1708030
- Other IDs
- ID-RCB
- Acronym
- EXPLO-DMA
- Status last verified
- Apr 2020
- First submitted
- 13 Jul 2017
- Last updated
- 17 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Pain Memory Among Former Burned: Exploration of Functional Magnetic Resonance Imaging (fMRI).
- ClinicalTrials.gov ID
- NCT03224975
- Acronym / sponsor ID
- EXPLO-DMA / 1708030
- Conditions
- Magnetic Resonance Imaging, Neuronal Activity
- Keywords
- Pain, Brain responses, Neuroimaging, fMRI, Burn, Memory
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: failure to recruit
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 13 Feb 2018 (actual)
- Primary completion
- 25 Nov 2019 (actual)
- Study completion
- 25 Nov 2019 (actual)
- First posted
- 21 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two groups: 20 patients and 20 healthy volunteers
| Arm | Type | Receives |
|---|---|---|
| patients | Experimental | Other: fMRIPatient who was burned will have fMRI. |
| control group | Active comparator | Other: fMRIHealthy volunteers (control group) will have fMRI. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
- Affiliated or entitled to a social security
Key exclusion criteria (9 listed)
- Any contraindications to pass an fMRI test
- Neuropathic pains and psychiatric disorders
- Medical history of head injuries
- Burn presence
- Any contraindications to pass an fMRI test
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fMRIAlso: functional Magnetic Resonance Imaging (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 | control group, patients |
Primary outcome
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.
2 secondary outcomes
BOLD (blood-oxygen-level dependent) signal between control group for every conditions
Time frame: Months 3
BOLD (blood-oxygen-level dependent) signal between patients for every conditions
Time frame: Months 3
Results and safety
The study was stopped early (reason given: failure to recruit). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-Claude GETENET, MD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fMRI in people with Magnetic Resonance Imaging and Neuronal Activity, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: failure to recruit). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
BOLD (blood-oxygen-level dependent) signal between painful memories (time frame: Months 3). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2020.