NCT02559999

Brief Summary

Determine objective markers of pain perception remains a major scientific and medical issue. Various tools have been proposed to objectify pain, but their adaptability to different clinical contexts are limited. Our working hypothesis considers that the research for markers of immediate pain perception should be based on an electrophysiological approach, based on the combined analysis of EEG and autonomic responses.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable healthy

Geographic Reach
1 country

2 active sites

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

June 4, 2014

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

September 24, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 25, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
Last Updated

October 23, 2018

Status Verified

October 1, 2018

Enrollment Period

3.7 years

First QC Date

September 24, 2015

Last Update Submit

October 22, 2018

Conditions

Healthy

Keywords

Healthy VolunteersPainEEG

Outcome Measures

Primary Outcomes (1)

  • EEG Gamma power.

    The EGG signals are compared between a painful stimuli tonic to those evoked by non-painful stimuli.

    Baseline

Secondary Outcomes (3)

  • ratio of low to high frequency spectral powers

    Baseline

  • Magnitude of the sympathetic cutaneous reactivity

    Baseline

  • Amplitude of pupillary dilation

    Baseline

Study Arms (1)

EEG responses

OTHER

The study compares electroencephalographical responses (EEG) to painful stimuli tonic to those evoked by non-painful stimuli and with or without virtual reality

Other: Painful tonic stimuliOther: non-painful stimuli

Interventions

Painful tonic stimuliOTHER
EEG responses
non-painful stimuliOTHER
EEG responses

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Affiliate or beneficiary of social security
  • Signature of consent

You may not qualify if:

  • History of cardiovascular disease (vagal syncope, hypertension, etc ...), renal, metabolic (diabetes ...), psychiatric (depression, etc ...) or neurological (seizure, etc ...) syndromes;
  • Reynaud's syndrome;
  • Raynaud's disease;
  • Acrocyanosis;
  • Known rhythm disorders;
  • Participation at the same time in another clinical trial;
  • Taking a medical treatment;
  • Suffering from acute (complaint of pain in the week before the test) or chronic pain,
  • Allergic to conductive gel for electrodes.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospices Civils de LYON

Lyon, 69500, France

Location

CHU de SAINT-ETIENNE

Saint-Etienne, 42000, France

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Roland PEYRON, MD

    CHU de SAINT-ETIENNE

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 24, 2015

First Posted

September 25, 2015

Study Start

June 4, 2014

Primary Completion

February 28, 2018

Study Completion

February 28, 2018

Last Updated

October 23, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)