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OpenTrials
Completed

NCT Number: NCT02489162

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universitair Ziekenhuis Brussel

Jette, Brussels Capital, 1090, Belgium

About this study

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

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • unilateral peripheral facial nerve palsy
  • Mental capacity to give consent
  • The patient is able to sit independently

Exclusion criteria

  • Adults who have undertaken strenuous exercise within the last twenty-four hours
  • 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)
  • Adults with poor mobility (unable to lie prone).
  • Adults with a body mass index (BMI) >30 kg/m2 . Muscle measurements may be inaccurate with excessive subcutaneous tissue

Treatment and study plan

MyotonPRO

Device

MyotonPRO measurements of the biomechanical properties of facial mimic muscles

non-invasive electromyography (EMG)

Device

Gold standard technique for measuring muscle

Primary outcomes

  1. Muscle tone (Hz)

    Time frame: 12 months

    Determine the feasibility of the MyotonPRO for assessing biomechanical properties of mimic muscles.

Secondary outcomes

  1. stiffness (N/m)

    Time frame: 12 months

    Determine the feasibility of the MyotonPRO for assessing biomechanical properties of mimic muscles.

Other outcomes

  1. elasticity (Logarithmic decrement)

    Time frame: 12 months

    Determine the feasibility of the MyotonPRO for assessing biomechanical properties of mimic muscles.

Sponsors and collaborators

Lead sponsor

Universitair Ziekenhuis Brussel

Other

Registry information

Official study title

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

Acronym: MyotonPRO

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Jul 2, 2015
Registry last updated
Nov 18, 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.

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