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Facial PalsyFACE_REHAB_MEGNCT06809127

Brain Plasticity and Emotion Recognition in Patients With Facial Palsy Before & After Surgical Rehabilitation: MEG Study

A study testing Behavioral tasks with MEG recording in people with Facial Palsy and Surgery, run by Institut National de la Santé Et de la Recherche Médicale, France at 1 site in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Facial palsy (of one hemiface) affects the sensorimotor representation of the face of the patients, and possibly also their mental representation of emotional facial expressions. Read more about this study

Who is it for?
Ages 20 to 70 years
Conditions the study is for
Facial Palsy, Surgery
What is being tested?
Behavioral tasks with MEG recording
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteFrance
Study dates
26 Jun 2017to 27 Feb 2023
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 20 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • No history of psychiatric illness
  • Severe facial palsy (V or VI grade on House and Brackman scale)
  • No evolutive neurologic pathology beside the lesion of the VIIth nerve
  • Signature of informed consent
  • Being a member of, or beneficiary of, a social security scheme

Who cannot join

  • Evolutive neurological disease outside the lesion of the VIIth nerve
  • General pathology leading to neuropathy
  • Person unable to express his/her consent
  • Adult under a legal protection measure
  • Adult deprived of liberty by judicial or administrative decision.
  • Adult participating in another research protocol involving the human person or subjected to a period of exclusion from another research
Show all 10Show fewer
  • Claustrophobia
  • Implants or metallic objects (including eyeglasses) that are susceptible to pertrubate the MEG signal
  • Treatment with known action on the central nervous system (Excessive recreational use of psychotropic drugs, ongoing benzodiazepine therapy)
  • For the patients who will undergo a complementary structural MRI for MEG source localisation, additional exclusion criteria are the contraindications to MRI (including: pacemaker or neurosensitive stimulator or implanted defibrillator, anevrism or vascular malformation of the brain, cochlear implants, ferromagnetic objects or prosthesis in the eyes or brain, mechanical heart valve prosthesis, permanent eye makeup; pregnant or nursing women)

Trial locations and contacts

1 site in 1 country.

France1 site

  • Frederic TANKERE

    Paris, 75651

Other trials in France

About this study

Official title: Etude de la plasticité cérébrale et de la Reconnaissance Des émotions en magnétoencéphalographie Chez Les Patients paralysés Faciaux Avant et après réhabilitation Motrice de la Face

Facial palsy (of one hemiface) affects the sensorimotor representation of the face of the patients, and possibly also their mental representation of emotional facial expressions. Three surgical techniques are performed to rehabilitate the face motricity in patients with severe facial palsy: Facio-facial anastomosis (AFF), Hypoglosso-facial anastomosis (AHF), and Lengthening temporalis myoplasty (LTM). Our objective is to study brain plasticity and facial emotion recognition in patients with facial palsy before and after surgical rehabilitation, using non invasive magnetoencephalography (MEG) recording during motor and emotion recognition tasks.

Read the detailed description

Facial palsy (of one hemiface) affects the sensorimotor representation of the face of the patients, and possibly also their mental representation of emotional facial expressions. Patients with severe facial palsy can benefit from surgical rehabilitation, allowing them to recover the motor and expressive function of the face. Three surgical techniques are performed to rehabilitate facial palsy: Facio-facial anastomosis (AFF), Hypoglosso-facial anastomosis (AHF), and Lengthening temporalis myoplasty (LTM). Prinicipal objective is to study brain plasticity and facial emotion recognition in patients with facial palsy before and after surgical rehabilitation. For this, the investigators will use magnetoencephalography (MEG), which is a non-invasive brain imaging method with high temporal and good spatial resolution.

  1. First objective is to characterize the brain plasticity at a global level, independently of the surgical technique used. The investigators will use simple motor tasks consisting in performing different facial movements and a control index flexion task to examine the cortical plasticity associated with the restauration of the motor and expressive function of the face in patients with facial palsy.
  2. Second objective is to examine if the brain magnetic responses associated with the recognition of emotional faces are modified in the paralyzed patients. The investigators will study the brain responses to angry, sad, happy, and neutral faces in a simple emotion recognition task.

Twenty patients with facial palsy will be included in the study. They will undergo two visits, during which MEG will be recorded in two types of tasks: motor task and emotion recognition task (see below). One visit will take place before surgery. The second visit will take place after the surgical intervention and the face motor rehabilitation, 3 to 18 months after the 1st visit.

MOTOR TASK: The motor task will comprise 5 types of simple movements: eye blinks, smiling, tongue protraction, teeth greeting, index flexion. These movements will be performed repetitively - at a pace of about 1 movement every 2 second - in separate, randomly alternating, blocks of 24 movements of each type, for a total of 120 movements of each type.

EMOTION RECOGNITION TASK: A total of 320 faces will be presented to the patients. The faces will be distributed in 5 blocks of 16 different faces (8 male, 8 female), displaying each of 4 emotional expressions: happiness, anger, sadness, and neutral expression. Occasional suprised target faces will be added. The patient's task will be to report the occurrence of those faces by pressing a button in his/her dominant hand. The stimuli will be presented in random order in each block.

The investogators will analyze neuromagnetic activities at the sensor and source levels during the motor tasks (primary objective) and in response to the faces (secondary objective).

Being tested
Behavioral tasks with MEG recording
Keywords
facial palsy, brain plasticity, motor cortex, emotion, MEG
Medical subject headings
Facial Paralysis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Behavioral tasks with MEG recordingDevice

    The patients will undergo two visits, during which MEG will be recorded in two types of behavioral tasks: motor task and emotion recognition task. One visit will take place before surgery. The second visit will take place after the surgical intervention and the face motor rehabilitation, 3 to 18 months after the 1st visit.

Study groups in NCT06809127
Study groupRoleWhat they receive
Behavioral tasks with MEG recordingOther1. MOTOR TASK: Five types of simple movements will be performed: eye blinks, smiling, tongue protraction, teeth greeting, index flexion. A total of 120 movements of each type will be performed in a set of five blocks interspersed with short breaks. 2. EMOTION RECOGNITION TASK: Four emotional expressions will be presented: happiness, anger, sadness, and neutral expression. A total of 320 face stimuli will be presented in 5 blocks interspersed with short breaks. Occasional target faces displaying a suprised expression will be added. The patient's task will be to report the occurrence of those faces by pressing a button in his/her dominant hand.
Receives: Device: Behavioral tasks with MEG recording

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Magnetoencephalography (MEG) activities during facial motor tasks

    Magnetoencephalography (MEG) activities during the motor tasks

    Measured: between 3 and 18 months

Secondary outcomes (1)

  1. Magnetoencephalography (MEG) activities in reponse to emotional faces

    Magnetoencephalography (MEG) activities in reponse to sad, angry, happy, and neutral faces during the facial emotion recognition task

    Measured: between 3 and 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2025
  2. Study start26 Jun 2017
  3. Primary completion27 Feb 2023
  4. Study completion27 Feb 2023

Resources

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
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06809127
Sponsor's protocol ID
C16-70
Other IDs
2016-A01861-50
Acronym
FACE_REHAB_MEG
Status last verified
Jan 2026
First submitted
3 May 2017
Last updated
26 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Foirest C, Gatignol P, Bernat I, Lamas G, Tankere F. [Lengthening temporalis myoplasty for facial palsy reanimation after parotid surgery]. Rev Laryngol Otol Rhinol (Bord). 2013;134(4-5):259-65. French.

    PubMed 25252584

  • Garmi R, Labbe D, Coskun O, Compere JF, Benateau H. Lengthening temporalis myoplasty and brain plasticity: a functional magnetic resonance imaging study. Ann Chir Plast Esthet. 2013 Aug;58(4):271-6. doi: 10.1016/j.anplas.2013.03.002. Epub 2013 Apr 23.

    PubMed 23623628

  • Leonetti JP, Anderson DE, Marzo SJ, Origitano TC, Petruzzelli GJ. Intratemporal Grafting of the Facial Nerve following Lateral Skull Base Tumor Resection. Skull Base. 2007 May;17(3):181-6. doi: 10.1055/s-2007-977464.

    PubMed 17973031

  • Memarian N, Ferrari P, Macdonald MJ, Cheyne D, De Nil LF, Pang EW. Cortical activity during speech and non-speech oromotor tasks: a magnetoencephalography (MEG) study. Neurosci Lett. 2012 Oct 3;527(1):34-9. doi: 10.1016/j.neulet.2012.08.030. Epub 2012 Aug 25.

    PubMed 22926020

  • Miki K, Kakigi R. Magnetoencephalographic study on facial movements. Front Hum Neurosci. 2014 Jul 29;8:550. doi: 10.3389/fnhum.2014.00550. eCollection 2014.

    PubMed 25120453

  • Nakahara H, Nakasato N, Kanno A, Murayama S, Hatanaka K, Itoh H, Yoshimoto T. Somatosensory-evoked fields for gingiva, lip, and tongue. J Dent Res. 2004 Apr;83(4):307-11. doi: 10.1177/154405910408300407.

    PubMed 15044504

  • Nakamura A, Yamada T, Goto A, Kato T, Ito K, Abe Y, Kachi T, Kakigi R. Somatosensory homunculus as drawn by MEG. Neuroimage. 1998 May;7(4 Pt 1):377-86. doi: 10.1006/nimg.1998.0332.

    PubMed 9626677

  • Nakasato N, Itoh H, Hatanaka K, Nakahara H, Kanno A, Yoshimoto T. Movement-related magnetic fields to tongue protrusion. Neuroimage. 2001 Oct;14(4):924-35. doi: 10.1006/nimg.2001.0881.

    PubMed 11554811

  • Rijntjes M, Tegenthoff M, Liepert J, Leonhardt G, Kotterba S, Muller S, Kiebel S, Malin JP, Diener HC, Weiller C. Cortical reorganization in patients with facial palsy. Ann Neurol. 1997 May;41(5):621-30. doi: 10.1002/ana.410410511.

    PubMed 9153524

  • Salmelin R, Sams M. Motor cortex involvement during verbal versus non-verbal lip and tongue movements. Hum Brain Mapp. 2002 Jun;16(2):81-91. doi: 10.1002/hbm.10031.

    PubMed 11954058

  • Suzuki M, Wasaka T, Inui K, Kakigi R. Reappraisal of field dynamics of motor cortex during self-paced finger movements. Brain Behav. 2013 Nov;3(6):747-62. doi: 10.1002/brb3.186. Epub 2013 Oct 17.

    PubMed 24363977

  • Tankere F, Bernat I, Vitte E, Lamas G, Soudant J, Maisonobe T, Bouche P, Fournier E, Willer JC. [The hypolossal-facial anastomosis in man. A model for studying peripheral and central nervous system plasticity]. Rev Med Liege. 2004;59 Suppl 1:91-103. French.

    PubMed 15244163

  • Vvedensky VL, Prokofyev AO. Timing of Cortical Events Preceding Voluntary Movement. Neural Comput. 2016 Feb;28(2):286-304. doi: 10.1162/NECO_a_00802. Epub 2015 Dec 14.

    PubMed 26654207

  • Willer JC, Tankere F, Maisonobe T, Bernat I, Lamas G, Soudant J, Vitte E, Bouche P, Fournier E. Hypoglossal-facial anastomosis induced central plastic changes in the blink reflex circuitry. Mov Disord. 2002;17 Suppl 2:S53-7. doi: 10.1002/mds.10060. No abstract available.

    PubMed 11836756

  • Yang TT, Gallen CC, Schwartz BJ, Bloom FE. Noninvasive somatosensory homunculus mapping in humans by using a large-array biomagnetometer. Proc Natl Acad Sci U S A. 1993 Apr 1;90(7):3098-102. doi: 10.1073/pnas.90.7.3098.

    PubMed 8464929

Questions about this trial

What is this clinical trial studying?

A study testing Behavioral tasks with MEG recording in people with Facial Palsy and Surgery, run by Institut National de la Santé Et de la Recherche Médicale, France 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 5 inclusion and 10 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 26 Jan 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?

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?

Magnetoencephalography (MEG) activities during facial motor tasks (time frame: between 3 and 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06809127, which also lists 16 linked publications.

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 26 Jan 2026.

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