Objective Markers of Pain Perception in Humans

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02559999
• Other study ID #: 1308172
• Secondary ID: 2013-A01636-39
• Status: Completed
• Phase: N/A
• Start date: June 4, 2014
• Est. completion date: February 28, 2018

Study information

• Verified date: October 2018
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: February 28, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Healthy

Intervention

Other:
• Painful tonic stimuli

• non-painful stimuli

Locations

Country	Name	City	State
France	Hospices Civils de LYON	Lyon
France	CHU de SAINT-ETIENNE	Saint-etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EEG Gamma power.	The EGG signals are compared between a painful stimuli tonic to those evoked by non-painful stimuli.	Baseline
Secondary	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
Secondary	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
Secondary	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