Interest of Ultrasonography in Electroneuromyography: Single-blind Randomised Controlled Clinical Trial

Study Overview
=================
Brief Summary
-----------------
Echo-nerve tracking during an electroneuromyographic (ENMG) examination by identifying the optimal stimulation site would reduce the stimulation intensities delivered to the patient and thus improve the tolerance of this examination.

Official Title
-----------------
Interest of Ultrasonography in Electroneuromyography: Single-blind Randomised Controlled Clinical Trial

Conditions
-----------------
Electromyoneurography

Intervention / Treatment
-----------------
* Other: Electroneuromyography with ultrasound
* Other: Electroneuromyography without ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient requiring an electroneuromyogram whose indication allows the application of a standard protocol of examination. Patient that has given his/her free and informed consent. Patient that signed the consent form. Patient with an health insurance plan. The patient is at least 18 years old (≥). he patient is under 80 years old (≤). Exclusion Criteria: Patient with symptoms of neuropathy during the screening. Patient whose Neurological severity score (NSS) score is ≥ 3. Patient whose neurological examination is abnormal and suggestive of neuropathy. Patient presenting a pathology that could cause neuropathy (e.g. diabetes, renal failure, etc.). Patient already participating in a category 1 research study (Jardé law). Patient in an exclusion period determined by another study. Patient under the protection of justice, under guardianship or under curatorship. Patient refusing to sign the consent form. Patient for which it is impossible to provide information about the study. Pregnant patient, parturient, or breastfeeding.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: electroneuromyography<br> | Other: Electroneuromyography with ultrasound<br>* Patients whose electroneuromyography examination will be performed using an ultrasound<br>|
| Placebo Comparator: control<br> | Other: Electroneuromyography without ultrasound<br>* Patients whose electroneuromyography examination will be performed without ultrasound (fake tracking)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Supra-maximal stimulation intensity delivered by stimulation site on sensory nerves | unit : milliampere (mA) | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Supra-maximal stimulation intensity delivered by stimulation site on the motor nerves | unit : mA | Day 0 | 
| Sensitivity Amplitude per collection site | unit : microvolts (uV) | Day 0 | 
| Motor Amplitude per collection site | unit : Millivolts (mV) | Day 0 | 
| Total number of explored muscles | unit : number | Day 0 | 
| Number of explored unusual muscles | unit : number | Day 0 | 
| Overall examination time between the beginning of the stimulation and the end of the myography examination | unit : minutes | Day 0 | 
| Average time per explored site (total duration divided by the number of explored nerves and muscles) | unit : minutes | Day 0 | 
| Score of satisfaction | Likert scale that range from 1 (not satisfied at all ) to 4 (totally satisfied) | Day 0 | 
| Measurement of felt pain | Analogical visual scale of pain from 1 (no pain) to 100 (maximum pain) | Day 0 |