Normative Values Laser Nociceptive Evoked Potentials Depending on the Age

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: 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

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint Etienne, France, 42055
    • CHU de Saint Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: healthy volunteers; 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

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
composite outcomes : latencies (ms) and amplitudes (μV) of nociceptive evoked potential	Day 0

Secondary Outcome Measures

Outcome Measure	Time Frame
detection threshold (mJ/mm2)	Day 0
nociceptive threshold (mJ/mm2)	day 0

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Investigators: Principal Investigator: Christelle Creac'h, MD, CHU Saint Etienne

Study record dates

Study Major Dates

• Study Start: February 1, 2008
• Primary Completion (Actual): April 1, 2012
• Study Completion (Actual): December 1, 2013

Study Registration Dates

• First Submitted: August 20, 2015
• First Submitted That Met QC Criteria: August 20, 2015
• First Posted (Estimated): August 21, 2015

Study Record Updates

• Last Update Posted (Actual): November 15, 2023
• Last Update Submitted That Met QC Criteria: November 14, 2023
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Keywords: healthy volunteers
• Other Study ID Numbers: 0701035; 2007- A00535-48 (Other Identifier: AFSSAPS)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO