Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide
Clinical Trials in France / NCT05546307
Recruiting Not applicable

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

NCT05546307 · tracked via the Priya Life Science France tracker
Sponsor
Centre Hospitalier Universitaire, Amiens
Phase
Not applicable
Started
2022-09-15
Last updated
2025-06-04

Condition(s) studied

RelaxationSomatosensory Evoked PotentialsPatient Experience

Investigational drug(s) / intervention(s)

SSEPrelaxation session

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)

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

Study 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

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Variation of average rate of automatized artifacts rejection between both groups — 19 months
    Average rate of automatized artifacts rejection during 2 sessions of 1000 stimulations on the first stimulated limb to obtain the N13 wave

Trial sites (1)

FacilityCityRegionStatus
Amiens University Hospital Amiens Picardie Recruiting

More Centre Hospitalier Universitaire, Amiens trials in France

Augmented Bladder Tumor Detection Using Real Time Based Artificial Intelligence Recruiting
Amikacin Liposome Inhalation Suspension for Treatment of Mycobacterium Xenopi Pulmonary Infection Recruiting
Validation, in a Pediatric Population, of a French Translation of the MEPS/MEPI Score Recruiting
Motor Slowing and Its Lesion-related Correlates in Alzheimer's Disease Recruiting
Composite Tissue Allotransplantation of the Face: Anatomical and Functional Evaluation Recruiting

Other trials for the same condition

APA and Relaxation by Biofeedback in Patients With Haematological Malignancy Admitted in ICU Recruiting
Comparison of Two Relaxation Strategies Between Glasses, Virtual Reality Headset, and Without Relaxation Tool, in the Anxiety Preoperative of Orthopedic Adult Patients Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05546307 on ClinicalTrials.gov ↗ ← All trials in France