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临床试验/NCT06809127
NCT06809127已完成不适用

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

Institut National de la Santé Et de la Recherche Médicale, France1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2017年6月26日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
16
试验地点
1
主要终点
Magnetoencephalography (MEG) activities during facial motor tasks

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Basic Science
盲法
None

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

  • •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)

研究组 & 干预措施

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.

干预措施: Behavioral tasks with MEG recording (Device)

结局指标

主要结局

Magnetoencephalography (MEG) activities during facial motor tasks

时间窗: between 3 and 18 months

Magnetoencephalography (MEG) activities during the motor tasks

次要结局

  • Magnetoencephalography (MEG) activities in reponse to emotional faces(between 3 and 18 months)

研究者

发起方
Institut National de la Santé Et de la Recherche Médicale, France
申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

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