Amiens University Hospital
Amiens, Picardie, 80054, France
Location status: Recruiting
Location contact
Caroline CARRE
CONTACT
Philippe-Edouard MERLE, Dr
SUB_INVESTIGATOR
William SZURHAJ, Pr
SUB_INVESTIGATOR
NCT Number: NCT05546307
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
Interested in participating?
Request Info18 year–70 year
All sexes
Interventional
Not applicable
Amiens, Picardie, 80054, France
Location status: Recruiting
Caroline CARRE
CONTACT
Philippe-Edouard MERLE, Dr
SUB_INVESTIGATOR
William SZURHAJ, Pr
SUB_INVESTIGATOR
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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)
The relaxation session will be performed by one of the 5 nurses trained in relaxation
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
Contact information is provided by the study sponsor or research team.
Centre Hospitalier Universitaire, Amiens
Other
Randomized, Single-blind Study Evaluating the Interest of Prior Relaxation on the Quality of the Recordings of the SomatoSensory Evoked Potentials
Acronym: RELAXPE
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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