跳至主要内容
临床试验/NCT03115203
NCT03115203招募中不适用

Morphometric Study of the Muscles of the Skin in MRI 3 Tesla in Patients With Facial Paralysis.

Centre Hospitalier Universitaire, Amiens2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2016年8月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
60
试验地点
2
主要终点
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.

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subject, for which a diagnosis of facial paralysis has been made, female or male, over 18 years of age.

排除标准

  • 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.))

研究组 & 干预措施

Healthy subject

Other

干预措施: Carry out the morphometric evaluation of the muscles of the skin, especially the large zygomatic muscle, in healthy subjects (Other)

Facial paralysis

Other

干预措施: Carry out the morphometric evaluation of the muscles of the skin, especially the large zygomatic muscle, in patients with sequelae of facial paralysis (Other)

结局指标

主要结局

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.

时间窗: 5 years

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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