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

NCT05546307 | Recruiting

• 1 other identifier: PI2019_843_0079
• Study Type: interventional
• Target: 242
• Locations: 1 country
• Sites: 1

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

Conditions

Relaxation; Somatosensory Evoked Potentials; Patient Experience

Keywords

Relaxation; Somatosensory Evoked Potentials; Patient experience

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

one relaxation session before the examination

EXPERIMENTAL

Other: SSEP; Other: relaxation session

No relaxation session before the examination

ACTIVE COMPARATOR

Other: SSEP

Interventions

SSEP OTHER

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)

No relaxation session before the examination; one relaxation session before the examination

relaxation session OTHER

The relaxation session will be performed by one of the 5 nurses trained in relaxation

one relaxation session before the examination

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Centre Hospitalier Universitaire, Amiens: lead

Study Sites (1)

Amiens University Hospital

Amiens, Picardie, 80054, France

RECRUITING

Central Study Contacts

Caroline CARRE

CONTACT

03 22 08 77 76; carre.caroline@chu-amiens.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 19, 2022
• Study Start: September 15, 2022
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: June 4, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)