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OpenTrials
Completed

NCT Number: NCT02559999

Objective Markers of Pain Perception in Humans

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.

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Key information

Conditions

Healthy Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–35 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospices Civils de LYON, Lyon, France

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Painful tonic stimuli

Other

non-painful stimuli

Other

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Saint Etienne

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
Sep 25, 2015
Registry last updated
Oct 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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