HealthyNCT02559999
Objective Markers of Pain Perception in Humans
A study testing Painful tonic stimuli and non-painful stimuli in people with Healthy, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
Trial summary
Determine objective markers of pain perception remains a major scientific and medical issue. Various tools have been proposed to objectify pain, but their adaptability to different clinical contexts are limited. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Painful tonic stimuli and non-painful stimuli
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesFrance
- Study dates
- 4 Jun 2014to 28 Feb 2018
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Affiliate or beneficiary of social security
- Signature of consent
Who cannot join
- History of cardiovascular disease (vagal syncope, hypertension, etc ...), renal, metabolic (diabetes ...), psychiatric (depression, etc ...) or neurological (seizure, etc ...) syndromes;
- Reynaud's syndrome;
- Raynaud's disease;
- Acrocyanosis;
- Known rhythm disorders;
- Participation at the same time in another clinical trial;
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- Taking a medical treatment;
- Suffering from acute (complaint of pain in the week before the test) or chronic pain,
- Allergic to conductive gel for electrodes.
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
Official title: Objective Markers of Pain Perception in Humans: a Study in Healthy Subjects
Determine objective markers of pain perception remains a major scientific and medical issue. Various tools have been proposed to objectify pain, but their adaptability to different clinical contexts are limited. Our working hypothesis considers that the research for markers of immediate pain perception should be based on an electrophysiological approach, based on the combined analysis of EEG and autonomic responses.
Read the detailed description
This project aims to study the cortical and autonomic responses induced by tonic painful stimulation compared to those induced by comparable sensory and stressful stimulations, by combining high density EEG, cutaneous sympathetic, cardiovascular and pupillary recordings.
- Conditions
- Healthy
- Being tested
- Painful tonic stimuli, non-painful stimuli
- Keywords
- Healthy Volunteers, Pain, EEG
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Painful tonic stimuliOther
non-painful stimuliOther
| Study group | Role | What they receive |
|---|---|---|
| EEG responses | Other | The study compares electroencephalographical responses (EEG) to painful stimuli tonic to those evoked by non-painful stimuli and with or without virtual reality Receives: Other: Painful tonic stimuli; Other: non-painful stimuli |
What is being measured
The primary outcome is the main question the study is designed to answer.
EEG Gamma power.
The EGG signals are compared between a painful stimuli tonic to those evoked by non-painful stimuli.
Measured: Baseline
Secondary outcomes (3)
ratio of low to high frequency spectral powers
The low and high frequency spectral powers are measured by an ECG Holter. The ratio are compared between a painful stimuli tonic to those evoked by non-painful stimuli.
Measured: Baseline
Magnitude of the sympathetic cutaneous reactivity
The sympathetic cutaneous reactivity is measured by an acquisition system (ME6000, MEDIMEX, France) with one electrode on the hand.
The magnitudes are compared between a painful stimuli tonic to those evoked by non-painful stimuli.
Measured: Baseline
Amplitude of pupillary dilation
The pupillary dilation is measured by the ISCAN® system (MA, USA). The amplitudes are compared between a painful stimuli tonic to those evoked by non-painful stimuli.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2015 (estimated)
- Study start4 Jun 2014
- Primary completion28 Feb 2018
- Study completion28 Feb 2018
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.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- 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
- NCT02559999
- Sponsor's protocol ID
- 1308172
- Other IDs
- 2013-A01636-39
- Status last verified
- Oct 2018
- First submitted
- 24 Sep 2015
- Last updated
- 23 Oct 2018
- 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 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Objective Markers of Pain Perception in Humans: a Study in Healthy Subjects
- ClinicalTrials.gov ID
- NCT02559999
- Acronym / sponsor ID
- 1308172
- Conditions
- Healthy
- Keywords
- Healthy Volunteers, Pain, EEG
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 4 Jun 2014 (actual)
- Primary completion
- 28 Feb 2018 (actual)
- Study completion
- 28 Feb 2018 (actual)
- First posted
- 25 Sep 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.
Determine objective markers of pain perception remains a major scientific and medical issue. Various tools have been proposed to objectify pain, but their adaptability to different clinical contexts are limited. Our working hypothesis considers that the research for markers of immediate pain perception should be based on an electrophysiological approach, based on the combined analysis of EEG and autonomic responses.
Detailed description
This project aims to study the cortical and autonomic responses induced by tonic painful stimulation compared to those induced by comparable sensory and stressful stimulations, by combining high density EEG, cutaneous sympathetic, cardiovascular and pupillary recordings.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EEG responses | Other | Other: Painful tonic stimuli, Other: non-painful stimuliThe study compares electroencephalographical responses (EEG) to painful stimuli tonic to those evoked by non-painful stimuli and with or without virtual reality |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Affiliate or beneficiary of social security
- Signature of consent
Key exclusion criteria (9 listed)
- History of cardiovascular disease (vagal syncope, hypertension, etc ...), renal, metabolic (diabetes ...), psychiatric (depression, etc ...) or neurological (seizure, etc ...) syndromes;
- Reynaud's syndrome;
- Raynaud's disease;
- Acrocyanosis;
- Known rhythm disorders;
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 |
|---|---|---|
| Painful tonic stimuli | Other | EEG responses |
| non-painful stimuli | Other | EEG responses |
Primary outcome
EEG Gamma power.
Time frame: Baseline
The EGG signals are compared between a painful stimuli tonic to those evoked by non-painful stimuli.
3 secondary outcomes
ratio of low to high frequency spectral powers
Time frame: Baseline
Magnitude of the sympathetic cutaneous reactivity
Time frame: Baseline
Amplitude of pupillary dilation
Time frame: Baseline
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 23 Oct 2018.
- 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 Painful tonic stimuli and non-painful stimuli 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 2 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: finished, as of the sponsor's last update on 23 Oct 2018. 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?
EEG Gamma power. (time frame: Baseline). 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 23 Oct 2018.