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OpenTrials
Completed

NCT Number: NCT02531048

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.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chu de Saint Etienne

Saint-Etienne, 42055, France

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. 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

laser stimulations on lower limbs

Device

20 laser stimulations for each site : back foot, outer face of the legs, and anterior thigh

laser stimulations cervical

Device

15 laser stimulations cervical areas below the ears.

20 laser stimulations for each site on the upper limbs

Device

20 laser stimulations for each site : back of the hands and arms front face

laser stimulations on face and neck

Device

15 lasers stimulations for each site : mandibular areas and areas below the ears.

Primary outcomes

  1. composite outcomes : latencies (ms) and amplitudes (μV) of nociceptive evoked potential

    Time frame: Day 0

Secondary outcomes

  1. detection threshold (mJ/mm2)

    Time frame: Day 0

  2. nociceptive threshold (mJ/mm2)

    Time frame: day 0

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Important dates

Study start
2008
Primary completion
2012
Study completion
2013
First posted
Aug 21, 2015
Registry last updated
Nov 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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