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Objective Markers of Pain Perception in Humans

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ClinicalTrials.gov Identifier: NCT02559999
Recruitment Status : Completed
First Posted : September 25, 2015
Last Update Posted : October 23, 2018
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Saint Etienne

Study Description
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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.

Condition or disease Intervention/treatment Phase
Healthy Other: Painful tonic stimuli Other: non-painful stimuli Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Objective Markers of Pain Perception in Humans: a Study in Healthy Subjects
Actual Study Start Date : June 4, 2014
Actual Primary Completion Date : February 28, 2018
Actual Study Completion Date : February 28, 2018
Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. EEG Gamma power. [ Time Frame: Baseline ]
    The EGG signals are compared between a painful stimuli tonic to those evoked by non-painful stimuli.


Secondary Outcome Measures :
  1. ratio of low to high frequency spectral powers [ Time Frame: 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.

  2. Magnitude of the sympathetic cutaneous reactivity [ Time Frame: 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.


  3. Amplitude of pupillary dilation [ Time Frame: 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02559999


Locations
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France
Hospices Civils de LYON
Lyon, France, 69500
CHU de SAINT-ETIENNE
Saint-etienne, France, 42000
Sponsors and Collaborators
Centre Hospitalier Universitaire de Saint Etienne
Investigators
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Principal Investigator: Roland PEYRON, MD CHU de SAINT-ETIENNE
More Information
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Responsible Party: Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier: NCT02559999    
Other Study ID Numbers: 1308172
2013-A01636-39 ( Other Identifier: ANSM )
First Posted: September 25, 2015    Key Record Dates
Last Update Posted: October 23, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:
Healthy Volunteers
Pain
EEG