HealthyNCT02531048
Normative Values Laser Nociceptive Evoked Potentials Depending on the Age
A study testing laser stimulations on lower limbs, laser stimulations cervical and 20 laser stimulations for each site on the upper limbs in people with Healthy, run by Centre Hospitalier Universitaire de Saint Etienne at 1 site in France.
Trial summary
Different neurological damage may alter the pain conduction systems centrally (spinothalamic pathway) or peripherally (small caliber sensory fibers A delta and C). The laser thermal stimulation selectively stimulates the pain pathways and generates nociceptive signals conveyed to the cortex. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- laser stimulations on lower limbs, laser stimulations cervical and 20 laser stimulations for each site on the upper limbs
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2008to Dec 2013
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- major
Who cannot join
- Neurological history
- Neuralgia history (> 3 months)
- Pathology can cause neuropathy (unbalanced thyroid dysfunction, diabetes, kidney failure, chronic hepatitis, HIV ...)
- Dermatological disorder known type of Lucite or photosensitivity
- Medical treatment analgesic, psychotropic or anti-epileptic underway
- Toxic acquired in the last 72 hours (alcohol, cannabis, other toxic ...)
Show all 9Show fewer
- Pregnant women
- Incapacitate to stand still
- Participation in another biomedical research in the field of pain in the three months prior to inclusion.
Trial locations and contacts
1 site in 1 country.
About this study
Different neurological damage may alter the pain conduction systems centrally (spinothalamic pathway) or peripherally (small caliber sensory fibers A delta and C). The laser thermal stimulation selectively stimulates the pain pathways and generates nociceptive signals conveyed to the cortex. Registering these cortical responses constitute the technical laser nociceptive evoked potentials. If these tests are routinely used, their interpretation must remain cautious especially in the elderly.
Read the detailed description
Different neurological damage may alter the pain conduction systems centrally (spinothalamic pathway) or peripherally (small caliber sensory fibers A delta and C). The laser thermal stimulation selectively stimulates the pain pathways and generates nociceptive signals conveyed to the cortex. Registering these cortical responses constitute the technical laser nociceptive evoked potentials. If these tests are routinely used, their interpretation must remain cautious especially in the elderly. Normal values that are available have been obtained in young subjects. However, various studies have shown that the integration of nociceptive messages depended on age. The aim of this study was to establish normal values of nociceptive evoked potentials for each age group of 18 to 75 years.
- Conditions
- Healthy
- Being tested
- laser stimulations on lower limbs, laser stimulations cervical, 20 laser stimulations for each site on the upper limbs, laser stimulations on face and neck
- Keywords
- healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laser stimulations on lower limbsDevice
20 laser stimulations for each site : back foot, outer face of the legs, and anterior thigh
laser stimulations cervicalDevice
15 laser stimulations cervical areas below the ears.
20 laser stimulations for each site on the upper limbsDevice
20 laser stimulations for each site : back of the hands and arms front face
laser stimulations on face and neckDevice
15 lasers stimulations for each site : mandibular areas and areas below the ears.
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteers | Experimental | Healthy volunteers are able to participate to this study. They must not have neurological troubles. They will have different stimulations :
* laser stimulations on lower limbs
* laser stimulations cervical
* 20 laser stimulations for each site on the upper limbs
* laser stimulations on face and neck Receives: Device: laser stimulations on lower limbs; Device: laser stimulations cervical; Device: 20 laser stimulations for each site on the upper limbs; Device: laser stimulations on face and neck |
What is being measured
The primary outcome is the main question the study is designed to answer.
composite outcomes : latencies (ms) and amplitudes (μV) of nociceptive evoked potential
Measured: Day 0
Secondary outcomes (2)
detection threshold (mJ/mm2)
Measured: Day 0
nociceptive threshold (mJ/mm2)
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 posted21 Aug 2015 (estimated)
- Study startFeb 2008
- Primary completionApr 2012
- Study completionDec 2013
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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Saint Etienne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Christelle Creac'h, MD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02531048
- Sponsor's protocol ID
- 0701035
- Other IDs
- 2007- A00535-48
- Status last verified
- Mar 2016
- First submitted
- 20 Aug 2015
- Last updated
- 15 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Normative Values Laser Nociceptive Evoked Potentials Depending on the Age
- ClinicalTrials.gov ID
- NCT02531048
- Acronym / sponsor ID
- 0701035
- Conditions
- Healthy
- Keywords
- healthy volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Apr 2012 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 21 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.
Different neurological damage may alter the pain conduction systems centrally (spinothalamic pathway) or peripherally (small caliber sensory fibers A delta and C). The laser thermal stimulation selectively stimulates the pain pathways and generates nociceptive signals conveyed to the cortex. Registering these cortical responses constitute the technical laser nociceptive evoked potentials. If these tests are routinely used, their interpretation must remain cautious especially in the elderly.
Detailed description
Different neurological damage may alter the pain conduction systems centrally (spinothalamic pathway) or peripherally (small caliber sensory fibers A delta and C). The laser thermal stimulation selectively stimulates the pain pathways and generates nociceptive signals conveyed to the cortex. Registering these cortical responses constitute the technical laser nociceptive evoked potentials. If these tests are routinely used, their interpretation must remain cautious especially in the elderly. Normal values that are available have been obtained in young subjects. However, various studies have shown that the integration of nociceptive messages depended on age. The aim of this study was to establish normal values of nociceptive evoked potentials for each age group of 18 to 75 years.
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: laser stimulations on lower limbs, Device: laser stimulations cervical, Device: 20 laser stimulations for each site on the upper limbs, Device: laser stimulations on face and neckHealthy volunteers are able to participate to this study. They must not have neurological troubles. They will have different stimulations : * laser stimulations on lower limbs * laser stimulations cervical * 20 laser stimulations for each site on the upper limbs * laser stimulations on face and neck |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- major
Key exclusion criteria (9 listed)
- Neurological history
- Neuralgia history (> 3 months)
- Pathology can cause neuropathy (unbalanced thyroid dysfunction, diabetes, kidney failure, chronic hepatitis, HIV ...)
- Dermatological disorder known type of Lucite or photosensitivity
- Medical treatment analgesic, psychotropic or anti-epileptic underway
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 |
|---|---|---|
| laser stimulations on lower limbs20 laser stimulations for each site : back foot, outer face of the legs, and anterior thigh | Device | healthy volunteers |
| laser stimulations cervical15 laser stimulations cervical areas below the ears. | Device | healthy volunteers |
| 20 laser stimulations for each site on the upper limbs20 laser stimulations for each site : back of the hands and arms front face | Device | healthy volunteers |
| laser stimulations on face and neck15 lasers stimulations for each site : mandibular areas and areas below the ears. | Device | healthy volunteers |
Primary outcome
composite outcomes : latencies (ms) and amplitudes (μV) of nociceptive evoked potential
Time frame: Day 0
2 secondary outcomes
detection threshold (mJ/mm2)
Time frame: Day 0
nociceptive threshold (mJ/mm2)
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 15 Nov 2023.
- 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.
Christelle Creac'h, 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 laser stimulations on lower limbs, laser stimulations cervical and 20 laser stimulations for each site on the upper limbs in people with Healthy, 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 1 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 15 Nov 2023. 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 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?
composite outcomes : latencies (ms) and amplitudes (μV) of nociceptive evoked potential (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 15 Nov 2023.