The Role of a Device to Evaluate the Neuromuscular Function in Assessing Muscle in Facial Paralysis Patients (MyotonPRO)

The Role of MyotonPro in Assessing the Biomechanical Properties of Facial Muscles in Facial Paralysis Patients and Its Role in Monitoring Recovery Following Facial Reanimation Surgery

The objective of the research is to determine whether the MyotonPRO has a valid and reliable application in facial, head and neck surgery. In addition, the study aims to compare this new technology with current electromyography.

Study Overview

• Status: Completed
• Conditions: Facial Nerve Palsy
• Intervention / Treatment: Device: MyotonPRO; Device: non-invasive electromyography (EMG)

Detailed Description

Facial paralysis has significant aesthetic, functional and psycho-social morbidity. The diagnosis and monitoring of neuromuscular recovery is limited to clinical examination, electromyography (EMG) and electroneurography (ENoG). EMG and ENoG is invasive for the patient and has practical and cost disadvantages. The MyotonPRO is a handheld device, which is pain-free and quick to use. Therefore this research is assessing MyotonPRO technology for this clinical application and may be effective at evaluating rehabilitative and surgical interventions. Phase 1 - Variation of measurements Phase 2 - Mimic muscle dysfunction assessment Phase 3 - Peri-operative Mimic and temporalis muscle assessment Phase 4 - Phase 3 including electromyography Phase 5 - Temporalis and mimic muscle assessment following facial reanimation surgery

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Brussels
    • Jette, Brussels, Belgium, 1090
      • Universitair Ziekenhuis Brussel

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. unilateral peripheral facial nerve palsy
2. Mental capacity to give consent
3. The patient is able to sit independently

Exclusion Criteria:

1. Adults who have undertaken strenuous exercise within the last twenty-four hours
2. Adults taking prescription medication with a known effect on the mechanical properties of muscle (e.g. benzodiazepines) or receiving antispasmodic medications (e.g. botulinum A toxin)
3. Adults with poor mobility (unable to lie prone).
4. Adults with a body mass index (BMI) >30 kg/m2 . Muscle measurements may be inaccurate with excessive subcutaneous tissue

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MyotonPRO; Experimental: Measurement of biomechanical properties of mimic muscles on the ipsilateral palsy side with the healthy contralateral side ( case - control design)	Device: MyotonPRO; MyotonPRO measurements of the biomechanical properties of facial mimic muscles; Device: non-invasive electromyography (EMG); Gold standard technique for measuring muscle
Active Comparator: Non-invasive electromyography (EMG); Comparing experimental intervention with gold standard	Device: MyotonPRO; MyotonPRO measurements of the biomechanical properties of facial mimic muscles; Device: non-invasive electromyography (EMG); Gold standard technique for measuring muscle

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle tone (Hz)	Determine the feasibility of the MyotonPRO for assessing biomechanical properties of mimic muscles.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
stiffness (N/m)	Determine the feasibility of the MyotonPRO for assessing biomechanical properties of mimic muscles.	12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
elasticity (Logarithmic decrement)	Determine the feasibility of the MyotonPRO for assessing biomechanical properties of mimic muscles.	12 months

Collaborators and Investigators

• Sponsor: Universitair Ziekenhuis Brussel
• Investigators: Principal Investigator: John Blythe, FRCS, European Face Centre, Universitair Ziekenhuis Brussel and University of Southhampton; Study Chair: Maurice Mommaerts, Prof.Dr.Mult, European Face Centre, Universitair Ziekenhuis Brussel; Study Director: Daniel Labbé, MD, Saint Martin Private Hospital Caen

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Actual): December 1, 2018
• Study Completion (Actual): April 1, 2019

Study Registration Dates

• First Submitted: June 10, 2015
• First Submitted That Met QC Criteria: June 30, 2015
• First Posted (Estimate): July 2, 2015

Study Record Updates

• Last Update Posted (Actual): April 17, 2019
• Last Update Submitted That Met QC Criteria: April 16, 2019
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Virus Diseases; Infections; Neurologic Manifestations; Disease Attributes; Stomatognathic Diseases; Mouth Diseases; DNA Virus Infections; Cranial Nerve Diseases; Herpesviridae Infections; Paralysis; Bell Palsy; Facial Paralysis; Facies; Facial Nerve Diseases
• Other Study ID Numbers: MiMuMS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No