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临床试验/NCT04218448
NCT04218448终止不适用

Evaluation of the Interest of Hypno-relaxation During Somatosensory Evoked Potentials

Fondation Hôpital Saint-Joseph2 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2020年1月13日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
26
试验地点
2
主要终点
duration of the somatosensory evoked potentials

研究概览

简要总结

Somatosensory evoked potentials corresponds to a neurophysiological exam that studies the functioning of the sensitivity pathways. It is often complementary to the imaging examination (MRI or scanner) and the electroneuromyogram which studies only the peripheral part of the sensory and motor pathways while the somatosensory evoked potentials are interested in their central and peripheral component.

The studied information are the potentials generated in the nervous system by the presentation of sensory stimulation. The examination makes it possible to study conduction times which will be defined as normal or pathological according to standards established on control subjects. Their indication is multiple: study of the repercussions of cervical osteoarthritis, specify the diagnosis of certain neuropathies, study of the conduction pathways at the medullary level in the event of trauma or inflammatory or other lesion.

In our study, the investigators will only be interested in the somatosensory evoked Potentials.

A study has shown that hypnotic suggestions to reduce the unpleasantness of pain triggered by thermal stimulation lead to a selective reduction of activity in the anterior cingulate cortex without modifying the activation of the somesthetic cortex.

Pain is, like all sensory stimulation, subject to the influences of attention, anticipation, mental imagery, previous conditioning. The fronto-cingular areas, activated by analgesics such as morphine, or by cortical stimulation are the same as those used by non-drug techniques such as hypnosis.

Therapeutic hypnosis is "a relational experience bringing into play physiological and psychological mechanisms allowing the individual to live better, reduce or eliminate an acute or chronic painful pathology" (Definition of Doctor Jean Marc Benhaiem).

The study of somatosensory evoked Potentials is a long examination (90 to 120 minutes), which can be uncomfortable for the patient (patient lying down, immobile and relaxed), not having to contract his muscles, especially if he is already painful due to his pathology or if it is difficult for him to remain motionless in the supine position. It is indeed necessary to average around 600 to 1000 responses (number of averages) to a small electrical simulation on each member studied.

The muscular contractions of an anxious and/or painful patient prolong the duration of the examination or even disturb the results, to the point of making it impossible to interpret the examination.

To our knowledge, hypnosis has already been used to improve muscle relaxation and reduce anxiety and pain during electromyograms, but hypnosis has never been used to improve the outcome of somatosensory evoked Potentials. Furthermore, if hypnosis modifies certain late cortical waves, it does not cause modification of the early waves and therefore does not disturb the results expected in our clinical practice.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

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

入选标准

  • Patient aged ≥ 18 years
  • Patient who was prescribed PES
  • French speaking patient
  • Patient affiliated to a social security scheme
  • Patient having given oral, free, informed and express consent

排除标准

  • Patient with severe pathologies of the peripheral nerve
  • Patient under guardianship or curatorship
  • Patient deprived of liberty
  • Pregnant woman
  • Patient denies
  • Psychotic patient

结局指标

主要结局

duration of the somatosensory evoked potentials

时间窗: one day

This correspond to the duration of the somatosensory evoked potentials exam in minuts, between the 2 groups.

次要结局

  • Quality of the somatosensory evoked potentials(one day)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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