Interest of Ultrasonography in Electroneuromyography: Single-blind Randomised Controlled Clinical Trial (US ENMG)

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.

Study Overview

• Status: Completed
• Conditions: Electromyoneurography
• Intervention / Treatment: Other: Electroneuromyography with ultrasound; Other: Electroneuromyography without ultrasound

• Study Type: Interventional
• Enrollment (Actual): 290
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nîmes, France, 30029
    • Nîmes University Hospital
  • Nîmes, France
    • Chu Nimes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Sarah COUDRAY, MD, Nîmes University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2019
• Primary Completion (Actual): January 28, 2020
• Study Completion (Actual): November 11, 2020

Study Registration Dates

• First Submitted: March 7, 2019
• First Submitted That Met QC Criteria: March 7, 2019
• First Posted (Actual): March 11, 2019

Study Record Updates

• Last Update Posted (Actual): August 5, 2021
• Last Update Submitted That Met QC Criteria: August 4, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: NIMAO/2018-01/SC-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No