Traumatic Long-term Memory of Pain in Humans (TRAUMADOL)

Civil Hospices of Lyon

Status: Enrolling

Conditions: Traumatic Memory; Pain

Treatments: Other: Electrical cutaneous stimulation and auditive stimulation (Principal Experimental phase); Other: Electrical cutaneous stimulation and auditive stimulation (Secondary Experimental phase); Other: Validation of virtual environment and auditive stimulation with virtual reality glasses (Pilot phase)

Study type: Interventional

Funder types: Other

Identifiers

NCT04189965

69HCL19_0413

Details and patient eligibility

About

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.

Enrollment: 180 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

180 participants in 3 patient groups

Pilot group

Other group

Description:

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.

Treatment:

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

Experimental group

Other group

Description:

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)

Treatment:

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

Experimental subgroup

Other group

Description:

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)

Treatment:

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