Interest of Prior Relaxation on the Recordings of the SomatoSensory Evoked Potentials

Study Overview
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Brief Summary
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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

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

Conditions
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Relaxation, Somatosensory Evoked Potentials, Patient Experience

Intervention / Treatment
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* Other: SSEP
* Other: relaxation session


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 exclusion criteria Exclusion Criteria: No availability of a technician trained in relaxation Patient's refusal to participate in the protocol

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: one relaxation session before the examination<br> | Other: SSEP<br>* Every patient presenting for a SSEP will be offered to participate to the study. If accepted, a randomization will determine whether the examination will be preceded by a relaxation session (Relax Group) or not (control group)<br>Other: relaxation session<br>* The relaxation session will be performed by one of the 5 nurses trained in relaxation<br>|
| Active Comparator: No relaxation session before the examination<br> | Other: SSEP<br>* Every patient presenting for a SSEP will be offered to participate to the study. If accepted, a randomization will determine whether the examination will be preceded by a relaxation session (Relax Group) or not (control group)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of average rate of automatized artifacts rejection between both groups | Average rate of automatized artifacts rejection during 2 sessions of 1000 stimulations on the first stimulated limb to obtain the N13 wave | 19 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Relaxation, Somatosensory Evoked Potentials, Patient experience