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NCT Number: NCT05546307

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

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Amiens University Hospital

Amiens, Picardie, 80054, France

Location status: Recruiting

Location contact

Caroline CARRE

CONTACT

[email protected]

03 22 08 77 76

Philippe-Edouard MERLE, Dr

SUB_INVESTIGATOR

William SZURHAJ, Pr

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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)

relaxation session

Other

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

Primary outcomes

  1. Variation of average rate of automatized artifacts rejection between both groups

    Time frame: 19 months

    Average rate of automatized artifacts rejection during 2 sessions of 1000 stimulations on the first stimulated limb to obtain the N13 wave

Study contacts

Contact information is provided by the study sponsor or research team.

Caroline CARRE

CONTACT

[email protected]

03 22 08 77 76

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study title

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

Acronym: RELAXPE

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Sep 19, 2022
Registry last updated
Jun 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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