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

Electromyoneurography Clinical Trial

— US ENMG  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03868189
• Other study ID #: NIMAO/2018-01/SC-01
• Status: Completed
• Phase: N/A
• Start date: April 4, 2019
• Est. completion date: November 11, 2020

Study information

• Verified date: August 2021
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 290
• Est. completion date: November 11, 2020
• Est. primary completion date: January 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Electromyoneurography

Intervention

Other:
• Electroneuromyography with ultrasound
Patients whose electroneuromyography examination will be performed using an ultrasound
• Electroneuromyography without ultrasound
Patients whose electroneuromyography examination will be performed without ultrasound (fake tracking)

Locations

Country	Name	City	State
France	CHU Nîmes	Nîmes
France	Nîmes University Hospital	Nîmes

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

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