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NCT Number: NCT04189965

Traumatic Long-term Memory of Pain in Humans

Few studies have focused on understanding the mechanisms underlying pain memory in humans. Thus, this project aims to investigate the link between pain memorisation and memorisation of the associated context by addressing the issue of pain conditioning. The study is composed of two successive parts: one pilot then one experimental. The goal is to understand pain memorisation processes by analysing the parallel between pain memorisation and memorisation of a traumatic event. By using immersive virtual reality, investigators aim to show that contextual pain conditioning is associated with : 1- a specific neural networks; 2- a reactivation of vegetative and behavioural reactions related to pain as well as electro-physiological markers when re-exposure to the specific pain-conditioning-context; 3- an implicit hypermnesia of the pain-associated context and a struggle to extinguish conditioning; 4- a favoured elaboration of false memories of the contextual pain. The emitted hypothesis suggests that a cortical and behavioural mnemonic trace is created during encoding of pain in association with its context, and that the latter can reactivate although the pain itself has disappeared. This implicit cortical mnemonic trace, evoked by the simple pain-associated context, could explain the notion of pain print persisting at long-term in patients suffering from chronic pain.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms Traumatic Memory

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Neurologique,

Bron, 69677, France

Location status: Recruiting

Location contact

Luis GARCIA-LARREA, MD

CONTACT

[email protected]

4 72 35 78 88 ext. +33

Luis GARCIA-LARREA, MD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Healthy subject
  • Subject between 18 and 50 years old
  • Subjects having given their written consent
  • Subjects with health insurance

Exclusion criteria

  • Prior addiction to drugs
  • Prior neurological issues
  • Chronic pain (neuropathic or non-neuropathic)
  • Pregnant/breast-feeding women
  • Absence of efficient contraception method for the duration of the study (1 month) for participants of procreation age (no inclusion limitation for male participants of procreation age)
  • Subjects under chronic analgesic treatment or having taken an analgesic treatment in the 24 h preceding the experiment
  • Heart issues
  • Subjects under justice surveillance
  • Subjects participating in another study which inclusion period overlaps with the one from this study

Treatment and study plan

Validation of virtual environment and auditive stimulation with virtual reality glasses (Pilot phase)

Other

The goal of this phase is the development of the experimental protocol in virtual reality. Virtual environment will be checked and auditive stimulation will be graduated.

Electrical cutaneous stimulation and auditive stimulation (Principal Experimental phase)

Other

This phase is the principal step of the study: during moving in virtual environment, electrical stimulation on one hand and auditive stimulation will be applied. EEG, ECG and skin conductance will be measured during conditioning phase and extinction phase (day 1, 30 minutes each phase). Behavioral measures will be done throughout the 3 sessions (day 1, day 2 and day 30)

Electrical cutaneous stimulation and auditive stimulation (Secondary Experimental phase)

Other

This phase is the same of the Principal Experimental phase except for the EEG that will not be performed.

Primary outcomes

  1. Measurement of electrophysiological (EEG) changes during a pain conditioning set up and its extinction

    Time frame: day 1

    The EEG will be done throughout the conditioning phase and the extinction phase (30 minutes each)conducted during the first session of the experiment (Day 1)

  2. Measurement of vegetative (electrodermal, electrocardiac) changes during a pain conditioning set up and its extinction

    Time frame: day 1

    The cutaneous response and electro-cardiographic activity will be done throughout the conditioning phase and the extinction phase (30 minutes each)conducted during the first session of the experiment (Day 1)

Secondary outcomes

  1. Assessment of short-term memory of an environment according to whether it is associated with a painful stimulation or not

    Time frame: day 2

    This outcome is evaluated by combined tests:

    • Free recall test: the subjects will have to quote a maximum of memorized objects during the conditioning phase
    • Recognition test: the objects present in the environment as well as objects not present in the environment will be presented randomly on a screen. Subjects should indicate whether the object in question was present in the environment or not.

  2. Assessment of long-term memory of an environment according to whether it is associated with a painful stimulation or not

    Time frame: day 30

    This outcome is evaluated by combined tests:

    • Free recall test: the subjects will have to quote a maximum of memorized objects during the conditioning phase
    • Recognition test: the objects present in the environment as well as objects not present in the environment will be presented randomly on a screen. Subjects should indicate whether the object in question was present in the environment or not.

  3. Assessment subject capacity to create false memory of environment according to the associated stimulation (pain or no pain)

    Time frame: day 2

    Questionnaire will be conducted on environment (presence or absence of different objects) to assess false memories

  4. Assessment subject capacity to create false memory of environment according to the associated stimulation (pain or no pain)

    Time frame: day 30

    Questionnaire will be conducted on environment (presence or absence of different objects) to assess false memories

  5. Eye-tracking measurements, to assess the exploration of different contexts according to their nature

    Time frame: Day 1

    An Eye-tracking system will be included in the Virtual Reality glasses (used during conditioning and extinction) to assess eye-movement during exploration of the environment

  6. Assessment of the total duration needed for total extinction

    Time frame: 30 minutes

    The amount of time needed for vegetative reactions to go back to baseline will be assessed during the extinction phase

Study contacts

Contact information is provided by the study sponsor or research team.

Luis GARCIA-LARREA, MD

CONTACT

[email protected]

4 72 35 78 88 ext. +33

Maud FROT

CONTACT

[email protected]

4 72 35 78 88 ext. +33

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

Traumatic Long-term Memory of Pain - Pain Conditioning Study in Humans

Acronym: TRAUMADOL

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Dec 9, 2019
Registry last updated
Aug 8, 2023

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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