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

Relaxation Clinical Trial

— RELAXPE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05546307
• Other study ID #: PI2019_843_0079
• Status: Recruiting
• Phase: N/A
• Start date: September 15, 2022
• Est. completion date: March 2024

Study information

• Verified date: September 2022
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: Caroline CARRE
• Phone: 03 22 08 77 76
• Email: carre.caroline[@]chu-amiens.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 242
• Est. completion date: March 2024
• Est. primary completion date: March 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Patient Experience
• Relaxation

Intervention

Other:
• SSEP
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)
• relaxation session
The relaxation session will be performed by one of the 5 nurses trained in relaxation

Locations

Country	Name	City	State
France	Amiens University Hospital	Amiens	Picardie

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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