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Completed

NCT Number: NCT03868189

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Nîmes, Nîmes, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Electroneuromyography with ultrasound

Other

Patients whose electroneuromyography examination will be performed using an ultrasound

Electroneuromyography without ultrasound

Other

Patients whose electroneuromyography examination will be performed without ultrasound (fake tracking)

Primary outcomes

  1. Supra-maximal stimulation intensity delivered by stimulation site on sensory nerves

    Time frame: Day 0

    unit : milliampere (mA)

Secondary outcomes

  1. Supra-maximal stimulation intensity delivered by stimulation site on the motor nerves

    Time frame: Day 0

    unit : mA

  2. Sensitivity Amplitude per collection site

    Time frame: Day 0

    unit : microvolts (uV)

  3. Motor Amplitude per collection site

    Time frame: Day 0

    unit : Millivolts (mV)

  4. Total number of explored muscles

    Time frame: Day 0

    unit : number

  5. Number of explored unusual muscles

    Time frame: Day 0

    unit : number

  6. Overall examination time between the beginning of the stimulation and the end of the myography examination

    Time frame: Day 0

    unit : minutes

  7. Average time per explored site (total duration divided by the number of explored nerves and muscles)

    Time frame: Day 0

    unit : minutes

  8. Score of satisfaction

    Time frame: Day 0

    Likert scale that range from 1 ("not satisfied at all ") to 4 ("totally satisfied")

  9. Measurement of felt pain

    Time frame: Day 0

    Analogical visual scale of pain from 1 (no pain) to 100 (maximum pain)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Acronym: US ENMG

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 11, 2019
Registry last updated
Dec 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.