NCT05546307 Interest of Prior Relaxation on the Recordings of the SomatoSensory Evoked Potentials
| NCT ID | NCT05546307 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier Universitaire, Amiens |
| Condition | Relaxation |
| Study Type | INTERVENTIONAL |
| Enrollment | 242 participants |
| Start Date | 2022-09-15 |
| Primary Completion | 2025-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 242 participants in total. It began in 2022-09-15 with a primary completion date of 2025-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05546307 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Relaxation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05546307 currently recruiting?
Yes, NCT05546307 is actively recruiting participants. Contact the research team at carre.caroline@chu-amiens.fr for enrollment information.
Where is the NCT05546307 trial being conducted?
This trial is being conducted at Amiens, France.
Who is sponsoring the NCT05546307 clinical trial?
NCT05546307 is sponsored by Centre Hospitalier Universitaire, Amiens. The trial plans to enroll 242 participants.