Assessment of Correlation Between Changes of Shear Wave Elastography and Surface Electromyogram of the Masseter (EVEREST)

November 5, 2015 updated by: Centre Hospitalier Universitaire de Saint Etienne

Assessment of Correlation Between Changes of Shear Wave Elastography and Surface Electromyogram of the Masseter, in Rest and Maximal Voluntary Contraction

Diagnoses and follow up of muscles diseases lack imaging. Severity assessment of masticatory dysfunction and follow up of treatment effectiveness is currently based only on clinical features. Supersonic ShearWave Imaging® is a new, non-invasive, non-irradiating and dynamic imaging technique that uses ultrasound and allows shear wave elastic modulus in a muscle in order to study its viscoelastic properties.

In this study, the investigators study the correlation between changes of shear wave elastography modulus and surface electromyogram features of the masseters between rest and maximal voluntary contraction.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Saint-Etienne, France, 42055
        • CHU DE SAINT-ETIENNE

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • People with social security.
  • People aged 20 to 40 years, of both sexes.
  • People that gave and signed consent to participate in the study.

Exclusion Criteria:

  • Any concomitant muscle disease (myopathy, myositis…)
  • Botulinum toxin injections in the masseter in the last 3 months preceding the study.
  • Any treatment that induces muscular effect (baclofen, benzodiazepine)
  • Bruxism or any masticatory apparatus disease
  • Any surgery of the masticatory apparatus

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
  • ultrasound exam by Supersonic Shear Imaging® technique
  • EMG examination by electromyograph Keypoint system.
Device: Ultrasound exam by Supersonic Shear Imaging® technique
Each of the two observers performs twice ultrasound examination and measures of the masseter thickness and its elastic modulus, at rest and maximal voluntary contraction.
Device: EMG examination by electromyograph Keypoint system
Experimented neurologist performs EMG examination.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Elastic modulus using Supersonic Shear Imaging® technique on superficial and deep masseter parts at rest and maximal voluntary contraction.
Time Frame: Day 1 (inclusion day)
Day 1 (inclusion day)

Secondary Outcome Measures

Outcome Measure
Time Frame
Thickness of the whole masseter mesured by Supersonic Shear Imaging® technique
Time Frame: Day 1 (inclusion day)
Day 1 (inclusion day)
Thickness of the masseter superficial part mesured by Supersonic Shear Imaging® technique
Time Frame: Day 1 (inclusion day)
Day 1 (inclusion day)
Thickness of the masseter deep part mesured by Supersonic Shear Imaging® technique
Time Frame: Day 1 (inclusion day)
Day 1 (inclusion day)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Investigators

  • Principal Investigator: Claire BOUTET, MD, CHU DE SAINT-ETIENNE

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

May 1, 2015

Study Completion (Actual)

May 1, 2015

Study Registration Dates

First Submitted

April 9, 2015

First Submitted That Met QC Criteria

April 21, 2015

First Posted (Estimate)

April 24, 2015

Study Record Updates

Last Update Posted (Estimate)

November 6, 2015

Last Update Submitted That Met QC Criteria

November 5, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1408203
  • 2015-A00073-46 (Other Identifier: ANSM)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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