Pain Clinical Trial
— TRAUMADOLOfficial title:
Traumatic Long-term Memory of Pain - Pain Conditioning Study 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.
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 |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Neurologique, | Bron |
Lead Sponsor | Collaborator |
---|---|
Hospices Civils de Lyon |
France,
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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