Objective Markers of Pain Perception in Humans

Objective Markers of Pain Perception in Humans: a Study in Healthy Subjects

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Other: Painful tonic stimuli; Other: non-painful stimuli

Detailed Description

This project aims to study the cortical and autonomic responses induced by tonic painful stimulation compared to those induced by comparable sensory and stressful stimulations, by combining high density EEG, cutaneous sympathetic, cardiovascular and pupillary recordings.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69500
    • Hospices Civils de Lyon
  • Saint-etienne, France, 42000
    • CHU DE SAINT-ETIENNE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Affiliate or beneficiary of social security
• Signature of consent

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: EEG responses; 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 stimuli; Other: non-painful stimuli

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EEG Gamma power.	The EGG signals are compared between a painful stimuli tonic to those evoked by non-painful stimuli.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ratio of low to high frequency spectral powers	The low and high frequency spectral powers are measured by an ECG Holter. The ratio are compared between a painful stimuli tonic to those evoked by non-painful stimuli.	Baseline
Magnitude of the sympathetic cutaneous reactivity	The sympathetic cutaneous reactivity is measured by an acquisition system (ME6000, MEDIMEX, France) with one electrode on the hand. The magnitudes are compared between a painful stimuli tonic to those evoked by non-painful stimuli.	Baseline
Amplitude of pupillary dilation	The pupillary dilation is measured by the ISCAN® system (MA, USA). The amplitudes are compared between a painful stimuli tonic to those evoked by non-painful stimuli.	Baseline

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2014
• Primary Completion (Actual): February 28, 2018
• Study Completion (Actual): February 28, 2018

Study Registration Dates

• First Submitted: September 24, 2015
• First Submitted That Met QC Criteria: September 24, 2015
• First Posted (Estimate): September 25, 2015

Study Record Updates

• Last Update Posted (Actual): October 23, 2018
• Last Update Submitted That Met QC Criteria: October 22, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Pain; Healthy Volunteers; EEG
• Other Study ID Numbers: 1308172; 2013-A01636-39 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No