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临床试验/NCT04189965
NCT04189965招募中不适用

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

Hospices Civils de Lyon2 个研究点 分布在 1 个国家目标入组 180 人开始时间: 2021年1月11日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
180
试验地点
2
主要终点
Measurement of electrophysiological (EEG) changes during a pain conditioning set up and its extinction

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Sequential
主要目的
Basic Science
盲法
None

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Healthy subject
  • Subject between 18 and 50 years old
  • Subjects having given their written consent
  • Subjects with health insurance

排除标准

  • 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

结局指标

主要结局

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

时间窗: 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

时间窗: 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)

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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Traumatic Long-term Memory of Pain in Humans | 临床试验