Traumatic Long-term Memory of Pain in Humans

NCT ID: NCT04189965

Last Updated: 2023-08-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-11
• Study Completion Date: 2027-02-28

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Pilot group

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.

Group Type: OTHER

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

Intervention Type: 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.

Experimental group

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)

Group Type: OTHER

Electrical cutaneous stimulation and auditive stimulation (Principal Experimental phase)

Intervention Type: 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 subgroup

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)

Group Type: OTHER

Electrical cutaneous stimulation and auditive stimulation (Secondary Experimental phase)

Intervention Type: OTHER

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

Interventions

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

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.

Intervention Type: OTHER

Electrical cutaneous stimulation and auditive stimulation (Principal Experimental phase)

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)

Intervention Type: OTHER

Electrical cutaneous stimulation and auditive stimulation (Secondary Experimental phase)

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hôpital Neurologique,

Bron, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Luis GARCIA-LARREA, MD

Role: CONTACT

luis-jose.garcia-larrea@chu-lyon.fr

4 72 35 78 88 ext. +33

Maud FROT

Role: CONTACT

maud.frot@univ-lyon1.fr

4 72 35 78 88 ext. +33

Facility Contacts

Luis GARCIA-LARREA, MD

Role: primary

luis-jose.garcia-larrea@chu-lyon.fr

4 72 35 78 88 ext. +33

Other Identifiers

69HCL19_0413

Identifier Type: -

Identifier Source: org_study_id