- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06809127
Brain Plasticity and Emotion Recognition in Patients With Facial Palsy Before & After Surgical Rehabilitation: MEG Study (FACE_REHAB_MEG)
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
Study Overview
Status
Conditions
Intervention / Treatment
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.
- 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.
- 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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Paris, France, 75651
- Frederic TANKERE
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Behavioral tasks with MEG recording
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Magnetoencephalography (MEG) activities during facial motor tasks
Time Frame: between 3 and 18 months
|
Magnetoencephalography (MEG) activities during the motor tasks
|
between 3 and 18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Magnetoencephalography (MEG) activities in reponse to emotional faces
Time Frame: between 3 and 18 months
|
Magnetoencephalography (MEG) activities in reponse to sad, angry, happy, and neutral faces during the facial emotion recognition task
|
between 3 and 18 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Frédéric TANKERE, MD, PhD, Assistance Publique - Hôpitaux de Paris
Publications and helpful links
General 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Hervochon R, Chaumon M, Ziri D, Foirest C, Schwartz D, George N, Tankere F. Cerebral Plasticity after Lengthening Temporalis Myoplasty in Facial Palsy: A Magnetoencephalography Study. Facial Plast Surg Aesthet Med. 2025 Mar-Apr;27(2):145-147. doi: 10.1089/fpsam.2023.0235. Epub 2024 May 13. No abstract available.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- C16-70
- 2016-A01861-50 (Registry Identifier: IDRCB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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