ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02489162
Recruitment Status : Active, not recruiting
First Posted : July 2, 2015
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Veerle Van Mossevelde, Universitair Ziekenhuis Brussel

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.

Condition or disease Intervention/treatment Phase
Facial Nerve Palsy Device: MyotonPRO Device: non-invasive electromyography (EMG) Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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
Actual Study Start Date : September 2015
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Muscle tone (Hz) [ Time Frame: 12 months ]
    Determine the feasibility of the MyotonPRO for assessing biomechanical properties of mimic muscles.


Secondary Outcome Measures :
  1. stiffness (N/m) [ Time Frame: 12 months ]
    Determine the feasibility of the MyotonPRO for assessing biomechanical properties of mimic muscles.


Other Outcome Measures:
  1. elasticity (Logarithmic decrement) [ Time Frame: 12 months ]
    Determine the feasibility of the MyotonPRO for assessing biomechanical properties of mimic muscles.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02489162


Locations
Belgium
Universitair Ziekenhuis Brussel
Jette, Brussels, Belgium, 1090
Sponsors and Collaborators
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

Responsible Party: Veerle Van Mossevelde, Data nurse, Universitair Ziekenhuis Brussel
ClinicalTrials.gov Identifier: NCT02489162     History of Changes
Other Study ID Numbers: MiMuMS
First Posted: July 2, 2015    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Paralysis
Facial Paralysis
Bell Palsy
Facies
Facial Nerve Diseases
Disease Attributes
Pathologic Processes
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Mouth Diseases
Stomatognathic Diseases
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Cranial Nerve Diseases