HealthyMODOUNCT02528578
Modulation of Painful Perception
A study testing thermal stimulation delivered by a thermode. and functional MRI in people with Healthy, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
Trial summary
The objective of the study is to evaluate in healthy volunteers, the influence of empathy on pain perception. It is widely accepted in the clinical management that the feeling of listening to the patients' pain would have a favorable influence on the pain, and conversely, the lack of listening would be aggravating. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- thermal stimulation delivered by a thermode. and functional MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 2 sitesFrance
- Study dates
- Jun 2013to Nov 2015
- 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 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Right handed
Who cannot join
- Pregnant or lactating women,
- Against-indications to MRI
- Drug intake of less than 12 hours,
- Neurological history or deficits, psychiatric, auditory or visual.
- Decline to participate
Trial locations and contacts
2 sites in 1 country.
France2 sites
Hospices Civils de LYON
Lyon, 69500
CHU de SAINT-ETIENNE
Saint-Etienne, 42000
About this study
The objective of the study is to evaluate in healthy volunteers, the influence of empathy on pain perception.
It is widely accepted in the clinical management that the feeling of listening to the patients' pain would have a favorable influence on the pain, and conversely, the lack of listening would be aggravating.
Read more
In this study, the volunteer will receive painful thermal stimuli in empathetic context (l, empathetic or non-empathetic) Two situations will oppose, one where the examiner neglect or minimize the suffering of the voluntary and the other or the contrary, the subject will receive empathy.
The first part of the project is to verify that the pain is influenced by the empathetic context. The second part will be conducted functional MRI, which should isolate the brain regions affected by other people's empathy for pain.
- Conditions
- Healthy
- Being tested
- thermal stimulation delivered by a thermode., functional MRI
- Keywords
- healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
thermal stimulation delivered by a thermode.Device
Empathetic context (neutral, empathetic, non-empathetic) when thermal stimulation
functional MRIOther
MRI realised with thermal stimulations and empathetic context (neutral, empathetic, non-empathetic) when thermal stimulation
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteers | Experimental | Not described Receives: Device: thermal stimulation delivered by a thermode.; Other: functional MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of the perceived pain assessed by the volunteer by a analog scale (VAS) at each thermal stimulation.
Measured: Day 0
Secondary outcomes (1)
blood-oxygen-level dependent (MRI)
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2015 (estimated)
- Study startJun 2013
- Primary completionNov 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Roland PEYRON, MD, Principal investigator, CHU de SAINT-ETIENNE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02528578
- Sponsor's protocol ID
- 1208141
- Other IDs
- 2012-A01232-41
- Acronym
- MODOU
- Status last verified
- Sep 2016
- First submitted
- 17 Aug 2015
- Last updated
- 26 Sep 2017
- 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 26 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Modulation of Painful Perception
- ClinicalTrials.gov ID
- NCT02528578
- Acronym / sponsor ID
- MODOU / 1208141
- Conditions
- Healthy
- Keywords
- healthy volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Jun 2013 (actual)
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 19 Aug 2015 (estimated)
- 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.
The objective of the study is to evaluate in healthy volunteers, the influence of empathy on pain perception.
It is widely accepted in the clinical management that the feeling of listening to the patients' pain would have a favorable influence on the pain, and conversely, the lack of listening would be aggravating.
In this study, the volunteer will receive painful thermal stimuli in empathetic context (l, empathetic or non-empathetic) Two situations will oppose, one where the examiner neglect or minimize the suffering of the voluntary and the other or the contrary, the subject will receive empathy.
The first part of the project is to verify that the pain is influenced by the empathetic context. The second part will be conducted functional MRI, which should isolate the brain regions affected by other people's empathy for pain.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers | Experimental | Device: thermal stimulation delivered by a thermode., Other: functional MRI |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Right handed
Key exclusion criteria (5 listed)
- Pregnant or lactating women,
- Against-indications to MRI
- Drug intake of less than 12 hours,
- Neurological history or deficits, psychiatric, auditory or visual.
- Decline to participate
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 |
|---|---|---|
| thermal stimulation delivered by a thermode.Empathetic context (neutral, empathetic, non-empathetic) when thermal stimulation | Device | healthy volunteers |
| functional MRIMRI realised with thermal stimulations and empathetic context (neutral, empathetic, non-empathetic) when thermal stimulation | Other | healthy volunteers |
Primary outcome
Intensity of the perceived pain assessed by the volunteer by a analog scale (VAS) at each thermal stimulation.
Time frame: Day 0
1 secondary outcome
blood-oxygen-level dependent (MRI)
Time frame: Day 0
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2017.
- 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.
Roland PEYRON, MD principal investigator
CHU de SAINT-ETIENNE
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing thermal stimulation delivered by a thermode. and functional MRI in people with Healthy, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites 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 1 inclusion and 5 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: finished, as of the sponsor's last update on 26 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intensity of the perceived pain assessed by the volunteer by a analog scale (VAS) at each thermal stimulation. (time frame: Day 0). 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 26 Sep 2017.