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

Facial Nerve Palsy Clinical Trial

— MyotonPRO  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02489162
• Other study ID #: MiMuMS
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: April 2019

Study information

• Verified date: October 2018
• Source: Universitair Ziekenhuis Brussel
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Bell Palsy
• Facial Nerve Diseases
• Facial Nerve Palsy
• Facial Paralysis
• Facies
• Paralysis

Intervention

Device:
• MyotonPRO
MyotonPRO measurements of the biomechanical properties of facial mimic muscles
• non-invasive electromyography (EMG)
Gold standard technique for measuring muscle

Locations

Country	Name	City	State
Belgium	Universitair Ziekenhuis Brussel	Jette	Brussels

Sponsors (1)

Lead Sponsor	Collaborator
Universitair Ziekenhuis Brussel

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	elasticity (Logarithmic decrement)	Determine the feasibility of the MyotonPRO for assessing biomechanical properties of mimic muscles.	12 months
Primary	Muscle tone (Hz)	Determine the feasibility of the MyotonPRO for assessing biomechanical properties of mimic muscles.	12 months
Secondary	stiffness (N/m)	Determine the feasibility of the MyotonPRO for assessing biomechanical properties of mimic muscles.	12 months