Facial Nerve PalsyMyotonPRONCT02489162
The Role of a Device to Evaluate the Neuromuscular Function in Assessing Muscle in Facial Paralysis Patients
A study testing MyotonPRO and non-invasive electromyography (EMG) in people with Facial Nerve Palsy, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Facial Nerve Palsy
- What is being tested?
- MyotonPRO and non-invasive electromyography (EMG)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBelgium
- Study dates
- Sep 2015to Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- unilateral peripheral facial nerve palsy
- Mental capacity to give consent
- The patient is able to sit independently
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Conditions
- Facial Nerve Palsy
- Being tested
- MyotonPRO, non-invasive electromyography (EMG)
- Medical subject headings
- Bell Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MyotonPRODevice
MyotonPRO measurements of the biomechanical properties of facial mimic muscles
non-invasive electromyography (EMG)Device
Gold standard technique for measuring muscle
| Study group | Role | What they receive |
|---|---|---|
| MyotonPRO | Experimental | Experimental: Measurement of biomechanical properties of mimic muscles on the ipsilateral palsy side with the healthy contralateral side ( case - control design) Receives: Device: MyotonPRO; Device: non-invasive electromyography (EMG) |
| Non-invasive electromyography (EMG) | Active comparator | Comparing experimental intervention with gold standard Receives: Device: MyotonPRO; Device: non-invasive electromyography (EMG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle tone (Hz)
Determine the feasibility of the MyotonPRO for assessing biomechanical properties of mimic muscles.
Measured: 12 months
Secondary outcomes (1)
stiffness (N/m)
Determine the feasibility of the MyotonPRO for assessing biomechanical properties of mimic muscles.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2018
- Study completionApr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial Nerve PalsyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitair Ziekenhuis Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John Blythe, FRCS, Principal investigator, European Face Centre, Universitair Ziekenhuis Brussel and University of SouthhamptonMaurice Mommaerts, Prof.Dr.Mult, Study chair, European Face Centre, Universitair Ziekenhuis BrusselDaniel Labbé, MD, Study director, Saint Martin Private Hospital Caen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02489162
- Sponsor's protocol ID
- MiMuMS
- Acronym
- MyotonPRO
- Status last verified
- Oct 2018
- First submitted
- 10 Jun 2015
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02489162
- Acronym / sponsor ID
- MyotonPRO / MiMuMS
- Conditions
- Facial Nerve Palsy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Universitair Ziekenhuis BrusselUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Apr 2019 (actual)
- First posted
- 2 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MyotonPRO | Experimental | Device: MyotonPRO, Device: non-invasive electromyography (EMG)Experimental: Measurement of biomechanical properties of mimic muscles on the ipsilateral palsy side with the healthy contralateral side ( case - control design) |
| Non-invasive electromyography (EMG) | Active comparator | Device: MyotonPRO, Device: non-invasive electromyography (EMG)Comparing experimental intervention with gold standard |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- unilateral peripheral facial nerve palsy
- Mental capacity to give consent
- The patient is able to sit independently
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MyotonPROMyotonPRO measurements of the biomechanical properties of facial mimic muscles | Device | MyotonPRO, Non-invasive electromyography (EMG) |
| non-invasive electromyography (EMG)Gold standard technique for measuring muscle | Device | MyotonPRO, Non-invasive electromyography (EMG) |
Primary outcome
Muscle tone (Hz)
Time frame: 12 months
Determine the feasibility of the MyotonPRO for assessing biomechanical properties of mimic muscles.
1 secondary outcome
stiffness (N/m)
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John Blythe, FRCS principal investigator
European Face Centre, Universitair Ziekenhuis Brussel and University of Southhampton
Maurice Mommaerts, Prof.Dr.Mult study chair
European Face Centre, Universitair Ziekenhuis Brussel
Daniel Labbé, MD study director
Saint Martin Private Hospital Caen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MyotonPRO and non-invasive electromyography (EMG) in people with Facial Nerve Palsy, run by Universitair Ziekenhuis Brussel at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle tone (Hz) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.