NCT02531048

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Feb 2008

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

August 20, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 21, 2015

Completed
Last Updated

November 15, 2023

Status Verified

March 1, 2016

Enrollment Period

4.2 years

First QC Date

August 20, 2015

Last Update Submit

November 14, 2023

Conditions

Healthy

Keywords

healthy volunteers

Outcome Measures

Primary Outcomes (1)

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

    Day 0

Secondary Outcomes (2)

  • detection threshold (mJ/mm2)

    Day 0

  • nociceptive threshold (mJ/mm2)

    day 0

Study Arms (1)

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

Device: laser stimulations on lower limbsDevice: laser stimulations cervicalDevice: 20 laser stimulations for each site on the upper limbsDevice: laser stimulations on face and neck

Interventions

laser stimulations on lower limbsDEVICE

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

healthy volunteers
laser stimulations cervicalDEVICE

15 laser stimulations cervical areas below the ears.

healthy volunteers
20 laser stimulations for each site on the upper limbsDEVICE

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

healthy volunteers
laser stimulations on face and neckDEVICE

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

healthy volunteers

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • major

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chu de Saint Etienne

Saint-Etienne, 42055, France

Location

Study Officials

  • Christelle Creac'h, MD

    CHU SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 20, 2015

First Posted

August 21, 2015

Study Start

February 1, 2008

Primary Completion

April 1, 2012

Study Completion

December 1, 2013

Last Updated

November 15, 2023

Record last verified: 2016-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)