跳至主要内容
临床试验/NCT05546307
NCT05546307招募中不适用

Randomized, Single-blind Study Evaluating the Interest of Prior Relaxation on the Quality of the Recordings of the SomatoSensory Evoked Potentials

Centre Hospitalier Universitaire, Amiens1 个研究点 分布在 1 个国家目标入组 242 人开始时间: 2022年9月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
242
试验地点
1
主要终点
Variation of average rate of automatized artifacts rejection between both groups

研究概览

简要总结

Many factors influence the quality and duration of SomatoSensory Evoked potentials (SSEP). Some are related to the technique : type of electrodes, intensity of stimulation, stimulation site ; others are related to the patient : poor state of relaxation of the patient generating muscle artefacts; hypersensitivity of the patient to electrical stimuli making the examination unpleasant; examination time considered too long. However, the patient's relaxed state is essential to the quality of the signal . Thus the duration of an examination is very variable : between 30 and 75 minutes for the upper limbs.... For several months, the investigators provide relaxation to some patients just before the examination. Results seem to be positive. The investigators aim to study the effect of relaxation session on the quality of the SSEP recordings. Fifteen-minutes relaxation session will be provided by a nurse trained to the relaxation.

The investigators will compare two groups : one group with one relaxation session before the examination and one group without relaxation session before the examination.

The investigators chose to study the influence of relaxation session on (i) the artifacts rejection rate by the machine for the recordings of SSEP by stimulation of the median nerve to the upper limbs (ii) the duration of the examination (iii) the patient experience

研究设计

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

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Any patient addressed for a study of the somatosensory evoked potentials in upper limbs
  • •Patients between 18 to 70 years old.
  • •Patients able to understand the instructions of the relaxation session and the examination.
  • •Patient providing informed consent

排除标准

  • •Exclusion Criteria:
  • •No availability of a technician trained in relaxation
  • •Patient's refusal to participate in the protocol

研究组 & 干预措施

one relaxation session before the examination

Experimental

干预措施: SSEP (Other)

one relaxation session before the examination

Experimental

干预措施: relaxation session (Other)

No relaxation session before the examination

Active Comparator

干预措施: SSEP (Other)

结局指标

主要结局

Variation of average rate of automatized artifacts rejection between both groups

时间窗: 19 months

Average rate of automatized artifacts rejection during 2 sessions of 1000 stimulations on the first stimulated limb to obtain the N13 wave

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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