NCT06809127

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

June 26, 2017

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 27, 2023

Completed
1.9 years until next milestone

First Posted

Study publicly available on registry

February 5, 2025

Completed
Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

5.7 years

First QC Date

May 3, 2017

Last Update Submit

January 23, 2026

Conditions

Facial PalsySurgery

Keywords

facial palsybrain plasticitymotor cortexemotionMEG

Outcome Measures

Primary Outcomes (1)

  • Magnetoencephalography (MEG) activities during facial motor tasks

    Magnetoencephalography (MEG) activities during the motor tasks

    between 3 and 18 months

Secondary Outcomes (1)

  • Magnetoencephalography (MEG) activities in reponse to emotional faces

    between 3 and 18 months

Study Arms (1)

Behavioral tasks with MEG recording

OTHER

1. 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.

Device: Behavioral tasks with MEG recording

Interventions

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.

Behavioral tasks with MEG recording

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Frederic TANKERE

Paris, 75651, France

Location

Related Publications (16)

  • 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.

    PMID: 25252584BACKGROUND

  • 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.

    PMID: 23623628BACKGROUND

  • 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.

    PMID: 17973031BACKGROUND

  • 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.

    PMID: 22926020BACKGROUND

  • 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.

    PMID: 25120453BACKGROUND

  • 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.

    PMID: 15044504BACKGROUND

  • 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.

    PMID: 9626677BACKGROUND

  • 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.

    PMID: 11554811BACKGROUND

  • 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.

    PMID: 9153524BACKGROUND

  • 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.

    PMID: 11954058BACKGROUND

  • 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.

    PMID: 24363977BACKGROUND

  • 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.

    PMID: 15244163BACKGROUND

  • 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.

    PMID: 26654207BACKGROUND

  • 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.

    PMID: 11836756BACKGROUND

  • 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.

    PMID: 8464929BACKGROUND

  • 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.

    PMID: 38738297RESULT

MeSH Terms

Conditions

Facial Paralysis

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Frédéric TANKERE, MD, PhD

    Assistance Publique - Hôpitaux de Paris

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2017

First Posted

February 5, 2025

Study Start

June 26, 2017

Primary Completion

February 27, 2023

Study Completion

February 27, 2023

Last Updated

January 26, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)