Normative Values Laser Nociceptive Evoked Potentials Depending on the Age

Healthy Clinical Trial

Official title:

Normative Values Laser Nociceptive Evoked Potentials Depending on the Age

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02531048
• Other study ID #: 0701035
• Secondary ID: 2007- A00535-48
• Status: Completed
• Phase: N/A
• Start date: February 2008
• Est. completion date: December 2013

Study information

• Verified date: March 2016
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2013
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• major

Exclusion Criteria:

• 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 ...)

• Pregnant women

• Incapacitate to stand still

• Participation in another biomedical research in the field of pain in the three months prior to inclusion.

Related Conditions & MeSH terms

• Healthy

Intervention

Device:
• laser stimulations on lower limbs
20 laser stimulations for each site : back foot, outer face of the legs, and anterior thigh
• laser stimulations cervical
15 laser stimulations cervical areas below the ears.
• 20 laser stimulations for each site on the upper limbs
20 laser stimulations for each site : back of the hands and arms front face
• laser stimulations on face and neck
15 lasers stimulations for each site : mandibular areas and areas below the ears.

Locations

Country	Name	City	State
France	Chu de Saint Etienne	Saint Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	composite outcomes : latencies (ms) and amplitudes (µV) of nociceptive evoked potential		Day 0
Secondary	detection threshold (mJ/mm2)		Day 0
Secondary	nociceptive threshold (mJ/mm2)		day 0