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

Primary Purpose

Facial Nerve Palsy

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
MyotonPRO
non-invasive electromyography (EMG)
Sponsored by
Universitair Ziekenhuis Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Facial Nerve Palsy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Universitair Ziekenhuis Brussel

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MyotonPRO

Non-invasive electromyography (EMG)

Arm Description

Experimental: Measurement of biomechanical properties of mimic muscles on the ipsilateral palsy side with the healthy contralateral side ( case - control design)

Comparing experimental intervention with gold standard

Outcomes

Primary Outcome Measures

Muscle tone (Hz)
Determine the feasibility of the MyotonPRO for assessing biomechanical properties of mimic muscles.

Secondary Outcome Measures

stiffness (N/m)
Determine the feasibility of the MyotonPRO for assessing biomechanical properties of mimic muscles.

Full Information

First Posted
June 10, 2015
Last Updated
April 16, 2019
Sponsor
Universitair Ziekenhuis Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT02489162
Brief Title
The Role of a Device to Evaluate the Neuromuscular Function in Assessing Muscle in Facial Paralysis Patients
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
April 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitair Ziekenhuis Brussel

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Facial Nerve Palsy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MyotonPRO
Arm Type
Experimental
Arm Description
Experimental: Measurement of biomechanical properties of mimic muscles on the ipsilateral palsy side with the healthy contralateral side ( case - control design)
Arm Title
Non-invasive electromyography (EMG)
Arm Type
Active Comparator
Arm Description
Comparing experimental intervention with gold standard
Intervention Type
Device
Intervention Name(s)
MyotonPRO
Intervention Description
MyotonPRO measurements of the biomechanical properties of facial mimic muscles
Intervention Type
Device
Intervention Name(s)
non-invasive electromyography (EMG)
Intervention Description
Gold standard technique for measuring muscle
Primary Outcome Measure Information:
Title
Muscle tone (Hz)
Description
Determine the feasibility of the MyotonPRO for assessing biomechanical properties of mimic muscles.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
stiffness (N/m)
Description
Determine the feasibility of the MyotonPRO for assessing biomechanical properties of mimic muscles.
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
elasticity (Logarithmic decrement)
Description
Determine the feasibility of the MyotonPRO for assessing biomechanical properties of mimic muscles.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John Blythe, FRCS
Organizational Affiliation
European Face Centre, Universitair Ziekenhuis Brussel and University of Southhampton
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maurice Mommaerts, Prof.Dr.Mult
Organizational Affiliation
European Face Centre, Universitair Ziekenhuis Brussel
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Daniel Labbé, MD
Organizational Affiliation
Saint Martin Private Hospital Caen
Official's Role
Study Director
Facility Information:
Facility Name
Universitair Ziekenhuis Brussel
City
Jette
State/Province
Brussels
ZIP/Postal Code
1090
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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