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

Not Applicable

Recruiting

• Conditions: Patient Experience; Relaxation; Somatosensory Evoked Potentials
• Interventions: Other: SSEP; Other: relaxation session

• Registration Number: NCT05546307
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-15
• Study First Submitted: 2022-09-15
• Study First Submitted QC: 2022-09-15
• Study First Posted: 2022-09-19
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-09
• Last Update Posted: 2024-07-10
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 242

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
one relaxation session before the examination	SSEP	-
one relaxation session before the examination	relaxation session	-
No relaxation session before the examination	SSEP	-

Primary Outcome Measures

Name	Time	Method
Variation of average rate of automatized artifacts rejection between both groups	19 months	Average rate of automatized artifacts rejection during 2 sessions of 1000 stimulations on the first stimulated limb to obtain the N13 wave

Trial Locations

Locations (1)

Amiens University Hospital; 🇫🇷 Amiens, Picardie, France