Facial ParalysisSIMOVI IRM 2NCT03115203
Morphometric Study of the Muscles of the Skin in MRI 3 Tesla in Patients With Facial Paralysis.
A study testing Carry out the morphometric evaluation of the muscles of the skin, especially the large zygomatic muscle, in patients with sequelae of facial paralysis and Carry out the morphometric evaluation of the muscles of the skin, especially the large zygomatic muscle, in healthy subjects in people with Facial Paralysis, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
The problem posed is the possibility of objectively assessing facial muscle mobility. Today, in patients with facial paralysis, the assessment of the deficit is carried out using a subjective scale such as the House Brackman [1] or EMG scale of the facial nerve but does not distinguish each muscle individually . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Facial Paralysis
- What is being tested?
- Carry out the morphometric evaluation of the muscles of the skin, especially the large zygomatic muscle, in patients with sequelae of facial paralysis and Carry out the morphometric evaluation of the muscles of the skin, especially the large zygomatic muscle, in healthy subjects
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 8 Aug 2016to 8 Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject, for which a diagnosis of facial paralysis has been made, female or male, over 18 years of age.
Who cannot join
- Pregnancy and lactation,
- a patient with a contra-indication to MRI (Claustrophobia, Pace Maker, Neurosurgical Clips, Vascular Clips, Cardiac Valves, V.peritoneal Valves, Cochlear Implant, Neuro-Stimulator, Intra-Orbital Metal Shards (Articular Prosthesis, Dental Prosthesis, Contact Glass, Insulin Pumps, Intrauterine Device, Tattoo, Piercing / Implants.))
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens Picardie
Amiens, Picardie, 80054
Stéphanie DAKPE, Dr, +33322668322, dakpe.stephanie@chu-amiens.fr
About this study
The problem posed is the possibility of objectively assessing facial muscle mobility.
Today, in patients with facial paralysis, the assessment of the deficit is carried out using a subjective scale such as the House Brackman [1] or EMG scale of the facial nerve but does not distinguish each muscle individually . Objective measurements of skin muscles such as thickness and volume, in preoperative assessment of a facial paralysis rehabilitation surgery, would be useful in order to choose the most appropriate surgical technique. Indeed, too much amyotrophy will contraindicate hypoglosso-facial anastomosis (VII-XII) and it will be preferable to propose a temporal elongation myoplasty or a reinfused free muscle flap.
Read more
Similarly, it would be useful to be able to objectively evaluate the recovery of muscle function after facial allo-transplantation.
Although electromyography has been developed since the work of Duchenne de Boulogne, little research has been carried out on the development of noninvasive methods to objectively characterize in vivo skin muscles (variation, position, orientation, morphometry). The main morphometric data of the skin muscles come from anatomical dissections.
Imaging of the skin muscles has not been specifically developed. Some studies have been carried out to visualize these muscles in MRI 1.5 Tesla in pathologies such as myasthenia gravis, facial paralysis, and labio-alveolo-palatine clefts for example.
The originality of the project is to develop a method allowing to establish a quantitative correlation between the movements of the face and the muscular changes. This correlation will be achieved by associating muscular morphological data derived from MRI acquisitions and cutaneous deformations resulting from clinical examinations. This non-invasive approach should make it possible to establish objective and reproducible indicators in patients with facial paralysis sequelae.
- Conditions
- Facial Paralysis
- Being tested
- Carry out the morphometric evaluation of the muscles of the skin, especially the large zygomatic muscle, in patients with sequelae of facial paralysis, Carry out the morphometric evaluation of the muscles of the skin, especially the large zygomatic muscle, in healthy subjects
- Keywords
- muscle skin, IRM 3 tesla
- Medical subject headings
- Facial Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carry out the morphometric evaluation of the muscles of the skin, especially the large zygomatic muscle, in patients with sequelae of facial paralysisOther
Carry out the morphometric evaluation of the muscles of the skin, especially the large zygomatic muscle, in patients with sequelae of facial paralysis
Carry out the morphometric evaluation of the muscles of the skin, especially the large zygomatic muscle, in healthy subjectsOther
Carry out the morphometric evaluation of the muscles of the skin, especially the large zygomatic muscle in healthy subjects (data obtained from the SIMOVI project being published).
| Study group | Role | What they receive |
|---|---|---|
| Facial paralysis | Other | Not described Receives: Other: Carry out the morphometric evaluation of the muscles of the skin, especially the large zygomatic muscle, in patients with sequelae of facial paralysis |
| Healthy subject | Other | Not described Receives: Other: Carry out the morphometric evaluation of the muscles of the skin, especially the large zygomatic muscle, in healthy subjects |
What is being measured
The primary outcome is the main question the study is designed to answer.
The measurement of the volume of the large zygomatic muscle in patients with facial paralysis compared to the mean volume of the large zygomatic muscle in healthy subjects.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start8 Aug 2016
- Primary completion8 Aug 2027 (estimated)
- Study completion8 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial ParalysisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03115203
- Sponsor's protocol ID
- PI2016_843_0013
- Acronym
- SIMOVI IRM 2
- Status last verified
- May 2026
- First submitted
- 31 Mar 2017
- Last updated
- 13 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Morphometric Study of the Muscles of the Skin in MRI 3 Tesla in Patients With Facial Paralysis.
- ClinicalTrials.gov ID
- NCT03115203
- Acronym / sponsor ID
- SIMOVI IRM 2 / PI2016_843_0013
- Conditions
- Facial Paralysis
- Keywords
- muscle skin, IRM 3 tesla
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 8 Aug 2016 (actual)
- Primary completion
- 8 Aug 2027 (estimated)
- Study completion
- 8 Aug 2027 (estimated)
- First posted
- 14 Apr 2017 (actual)
- 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 problem posed is the possibility of objectively assessing facial muscle mobility.
Today, in patients with facial paralysis, the assessment of the deficit is carried out using a subjective scale such as the House Brackman [1] or EMG scale of the facial nerve but does not distinguish each muscle individually . Objective measurements of skin muscles such as thickness and volume, in preoperative assessment of a facial paralysis rehabilitation surgery, would be useful in order to choose the most appropriate surgical technique. Indeed, too much amyotrophy will contraindicate hypoglosso-facial anastomosis (VII-XII) and it will be preferable to propose a temporal elongation myoplasty or a reinfused free muscle flap.
Similarly, it would be useful to be able to objectively evaluate the recovery of muscle function after facial allo-transplantation.
Although electromyography has been developed since the work of Duchenne de Boulogne, little research has been carried out on the development of noninvasive methods to objectively characterize in vivo skin muscles (variation, position, orientation, morphometry). The main morphometric data of the skin muscles come from anatomical dissections.
Imaging of the skin muscles has not been specifically developed. Some studies have been carried out to visualize these muscles in MRI 1.5 Tesla in pathologies such as myasthenia gravis, facial paralysis, and labio-alveolo-palatine clefts for example.
The originality of the project is to develop a method allowing to establish a quantitative correlation between the movements of the face and the muscular changes. This correlation will be achieved by associating muscular morphological data derived from MRI acquisitions and cutaneous deformations resulting from clinical examinations. This non-invasive approach should make it possible to establish objective and reproducible indicators in patients with facial paralysis sequelae.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Facial paralysis | Other | Other: Carry out the morphometric evaluation of the muscles of the skin, especially the large zygomatic muscle, in patients with sequelae of facial paralysis |
| Healthy subject | Other | Other: Carry out the morphometric evaluation of the muscles of the skin, especially the large zygomatic muscle, in healthy subjects |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subject, for which a diagnosis of facial paralysis has been made, female or male, over 18 years of age.
Key exclusion criteria (2 listed)
- Pregnancy and lactation,
- a patient with a contra-indication to MRI (Claustrophobia, Pace Maker, Neurosurgical Clips, Vascular Clips, Cardiac Valves, V.peritoneal Valves, Cochlear Implant, Neuro-Stimulator, Intra-Orbital Metal Shards (Articular Prosthesis, Dental Prosthesis, Contact Glass, Insulin Pumps, Intrauterine Device, Tattoo, Piercing / Implants.))
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 |
|---|---|---|
| Carry out the morphometric evaluation of the muscles of the skin, especially the large zygomatic muscle, in patients with sequelae of facial paralysisCarry out the morphometric evaluation of the muscles of the skin, especially the large zygomatic muscle, in patients with sequelae of facial paralysis | Other | Facial paralysis |
| Carry out the morphometric evaluation of the muscles of the skin, especially the large zygomatic muscle, in healthy subjectsCarry out the morphometric evaluation of the muscles of the skin, especially the large zygomatic muscle in healthy subjects (data obtained from the SIMOVI project being published). | Other | Healthy subject |
Primary outcome
The measurement of the volume of the large zygomatic muscle in patients with facial paralysis compared to the mean volume of the large zygomatic muscle in healthy subjects.
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2026.
Related trials for Facial Paralysis
Not yet recruiting
Deep-plane Facelift As A Staged Adjunct To Facial Reanimation : Functional And Aesthetic Outcomes in Comparison to Facial Reanimation Alone
Facial Palsy
RecruitingPhase 3
Steroids for Facial Nerve Function Protection in Post-surgical Vestibular Schwannoma Patients
Vestibular Schwannoma, Facial Nerve Paralysis
Recruiting
Eye-Tracking FP "A Pilot Study of the Quantitative Evaluation of the Attention Paid to Faces With Facial Palsy by the Eye-tracking Technology.
Eye-tracking, Facial Palsy
Not yet recruiting
Mindfulness in Nonflaccid Facial Paralysis
Facial Paralysis
Recruiting
Treatment for "Asymmetric Crying Facies"
Hemifacial Microsomia, Facial Nerve Paralysis
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carry out the morphometric evaluation of the muscles of the skin, especially the large zygomatic muscle, in patients with sequelae of facial paralysis and Carry out the morphometric evaluation of the muscles of the skin, especially the large zygomatic muscle, in healthy subjects in people with Facial Paralysis, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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 1 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 13 May 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stéphanie DAKPE, Dr (+33322668322, dakpe.stephanie@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The measurement of the volume of the large zygomatic muscle in patients with facial paralysis compared to the mean volume of the large zygomatic muscle in healthy subjects. (time frame: 5 years). 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 13 May 2026.