Traumatic Long-term Memory of Pain in Humans

NCT04189965 | Recruiting

• 1 other identifier: 69HCL19_0413
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain; Traumatic Memory

Keywords

Pain; Traumatic Long-term Memory

Outcome Measures

Primary Outcomes (2)

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

  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)

  day 1

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

  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)

  day 1

Secondary Outcomes (6)

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

  day 2

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

  day 30

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

  day 2

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

  day 30

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

  Day 1

Study Arms (3)

Pilot group

OTHER

Subjects are volunteers of 18 to 50 years of age that have given consent and that are affiliated to a social security. Overall, subjects must be in good health (no chronic pain, neuropathy or cardiac/respiratory issues etc.) and (for women) non-pregnant. The subject will be seated in an armchair. He will be asked to explore the virtual environment using virtual reality glasses to validate it. The subject will also have headphones and different shouts or noises will be broadcast and he will have to rate the level of dislike of each sound stimulation.

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

Experimental group

OTHER

Subjects are volunteers of 18 to 50 years of age that have given consent and that are affiliated to a social security. Overall, subjects must be in good health (no chronic pain, neuropathy or cardiac/respiratory issues etc.) and (for women) non-pregnant. The subject will be seated in an armchair. He will be asked to explore the virtual environment using virtual reality glasses. He will also have headphones and different shouts or noises will be broadcast and an electric stimulation glove to study in humans the mechanisms of long-term memory of pain by exploring the parallel between memory of pain and memory of a traumatic event. 3 sessions of stimulation will be done (D0, D2 and D30)

Other: Electrical cutaneous stimulation and auditive stimulation (Principal Experimental phase)

Experimental subgroup

OTHER

Subjects are volunteers of 18 to 50 years of age that have given consent and that are affiliated to a social security. Overall, subjects must be in good health (no chronic pain, neuropathy or cardiac/respiratory issues etc.) and (for women) non-pregnant. The subject will be seated in an armchair. He will be asked to explore the virtual environment using virtual reality glasses. He will also have headphones and different shouts or noises will be broadcast and an electric stimulation glove to study in humans the mechanisms of long-term memory of pain by exploring the parallel between memory of pain and memory of a traumatic event. 3 sessions of stimulation will be done (D0, D2 and D30)

Other: Electrical cutaneous stimulation and auditive stimulation (Secondary Experimental phase)

Interventions

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.

Pilot group

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)

Experimental group

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.

Experimental subgroup

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Prior addiction to drugs
• Prior neurological issues
• Chronic pain (neuropathic or non-neuropathic)
• Pregnant/breast-feeding women
• Subjects under chronic analgesic treatment or having taken an analgesic treatment in the 24 h preceding the experiment
• Heart issues
• Subjects under justice surveillance

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (1)

Hôpital Neurologique,

Bron, 69677, France

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Luis GARCIA-LARREA, MD

CONTACT

4 72 35 78 88; luis-jose.garcia-larrea@chu-lyon.fr

Maud FROT

CONTACT

4 72 35 78 88; maud.frot@univ-lyon1.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2019
• First Posted: December 9, 2019
• Study Start: January 11, 2021
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: August 8, 2023

Record last verified: 2023-08

Locations

FR (1)