Interest of Prior Relaxation on the Recordings of the SomatoSensory Evoked Potentials (RELAXPE)

Centre Hospitalier Universitaire, Amiens

Status: Enrolling

Conditions: Somatosensory Evoked Potentials; Patient Experience; Relaxation

Treatments: Other: relaxation session; Other: SSEP

Study type: Interventional

Funder types: Other

Identifiers

NCT05546307

PI2019_843_0079

Details and patient eligibility

About

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

Enrollment: 242 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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242 participants in 2 patient groups

one relaxation session before the examination

Experimental group

Treatment:

Other: SSEP

Other: relaxation session

No relaxation session before the examination

Active Comparator group

Treatment:

Other: SSEP