Objective Markers of Pain Perception in Humans

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Painful tonic stimuli; Other: non-painful stimuli

• Registration Number: NCT02559999
• Lead Sponsor: Centre Hospitalier Universitaire de Saint Etienne

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.

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 Timeline

• Study Start: 2014-06-04
• Study First Submitted: 2015-09-24
• Study First Submitted QC: 2015-09-24
• Study First Posted: 2015-09-25
• Primary Completion: 2018-02-28
• Study Completion: 2018-02-28
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-22
• Last Update Posted: 2018-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
EEG Gamma power.	Baseline	The EGG signals are compared between a painful stimuli tonic to those evoked by non-painful stimuli.

Secondary Outcome Measures

Name	Time	Method
Magnitude of the sympathetic cutaneous reactivity	Baseline	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.
Amplitude of pupillary dilation	Baseline	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.
ratio of low to high frequency spectral powers	Baseline	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.

Trial Locations

Locations (2)

CHU de SAINT-ETIENNE; 🇫🇷 Saint-etienne, France

Hospices Civils de LYON; 🇫🇷 Lyon, France