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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04189965
Other study ID # 69HCL19_0413
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 11, 2021
Est. completion date February 2027

Study information

Verified date August 2023
Source Hospices Civils de Lyon
Contact Luis GARCIA-LARREA, MD
Phone 4 72 35 78 88
Email luis-jose.garcia-larrea@chu-lyon.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 180
Est. completion date February 2027
Est. primary completion date February 2027
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
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.
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)
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.

Locations

Country Name City State
France Hôpital Neurologique, Bron

Sponsors (1)

Lead Sponsor Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 Assessment of short-term memory of an environment according to whether it is associated with a painful stimulation or not 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.
day 2
Secondary Assessment of long-term memory of an environment according to whether it is associated with a painful stimulation or not 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.
day 30
Secondary Assessment subject capacity to create false memory of environment according to the associated stimulation (pain or no pain) Questionnaire will be conducted on environment (presence or absence of different objects) to assess false memories day 2
Secondary Assessment subject capacity to create false memory of environment according to the associated stimulation (pain or no pain) Questionnaire will be conducted on environment (presence or absence of different objects) to assess false memories day 30
Secondary Eye-tracking measurements, to assess the exploration of different contexts according to their nature 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 Day 1
Secondary Assessment of the total duration needed for total extinction The amount of time needed for vegetative reactions to go back to baseline will be assessed during the extinction phase 30 minutes
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