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Clinical Trials/NCT04189965
NCT04189965
Recruiting
Not Applicable

Traumatic Long-term Memory of Pain - Pain Conditioning Study in Humans

Hospices Civils de Lyon1 site in 1 country180 target enrollmentJanuary 11, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Pain
Sponsor
Hospices Civils de Lyon
Enrollment
180
Locations
1
Primary Endpoint
Measurement of electrophysiological (EEG) changes during a pain conditioning set up and its extinction
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 11, 2021
End Date
February 2027
Last Updated
2 years ago
Study Type
Interventional
Study Design
Sequential
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

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

Time Frame: day 1

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)

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

Time Frame: day 1

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)

Secondary Outcomes

  • Assessment of the total duration needed for total extinction(30 minutes)
  • 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 30)
  • Eye-tracking measurements, to assess the exploration of different contexts according to their nature(Day 1)
  • Assessment of short-term memory of an environment according to whether it is associated with a painful stimulation or not(day 2)

Study Sites (1)

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