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

NCT ID: NCT05546307

Last Updated: 2025-06-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

242 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-15

Study Completion Date

2025-07-31

Brief Summary

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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

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Conditions

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Relaxation Somatosensory Evoked Potentials Patient Experience

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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one relaxation session before the examination

Group Type EXPERIMENTAL

SSEP

Intervention Type 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

Intervention Type OTHER

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

No relaxation session before the examination

Group Type ACTIVE_COMPARATOR

SSEP

Intervention Type 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)

Interventions

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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)

Intervention Type OTHER

relaxation session

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

Intervention Type OTHER

Eligibility Criteria

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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.

Exclusion Criteria

* No availability of a technician trained in relaxation
* Patient's refusal to participate in the protocol
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire, Amiens

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Amiens University Hospital

Amiens, Picardie, France

Site Status RECRUITING

Countries

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France

Central Contacts

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Caroline CARRE

Role: CONTACT

03 22 08 77 76

Facility Contacts

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Caroline CARRE

Role: primary

03 22 08 77 76

Other Identifiers

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PI2019_843_0079

Identifier Type: -

Identifier Source: org_study_id

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