跳至主要内容
临床试验/NCT05327985
NCT05327985终止不适用

STOCI: Three-dimensional Analysis of Obliquus Capitis Inferior Muscle Function in the Rotatory Form of Cervical Dystonia by Means of the Cone Beam Mode CT Scanning :Prospective Cohort Study

Fondation Ophtalmologique Adolphe de Rothschild1 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2024年9月10日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
21
试验地点
1
主要终点
Changes in posture and main movement rotation of the cervical spine

研究概览

简要总结

Cervical dystonia is the most common form of focal dystonia in adults (50-82%). It manifests itself by a abnormal attitude of the head, intermittent or permanent, due to involuntary contraction of the cervical muscles which appears or is accentuated on the occasion of voluntary movement and maintenance posture. The distribution of dystonic muscles is specific to each patient explaining the diversity of patterns encountered. The therapeutic management of DC is essentially local and symptomatic. It is based on the realization of injections of neuro botulinum toxin (BoNT) targeting target (dystonic) muscles responsible for involuntary movements or posture abnormal. Identifying the muscles involved is a step prerequisite for therapeutic intervention.The obliquus capitis inferior (OCI) also known as Lower Oblique belongs to the group of suboccipital muscles.It is the only suboccipital muscle that does not attach to the skull. Its unilateral contraction causes ipsilateral rotation of C1 therefore of the head. The length of the transverse process of the atlas gives it considerable rotary efficiency. It is described as the cephalic rotation starter muscle. It would perform the 30 first degrees of rotation. The rotation of the whole column cervical would then be continued by the synergistic action of the muscle contralateral sternocleidomatoid and Spl. ipsilateral. The level of joint complex C1-C2 the amplitude of rotation corresponds to approximately 50% of the total rotation of the cervical spine. In order to better understand the part played by the OCI muscle in the disorganization of posture and cervical movements in the axial plane (plane of rotation) in the rotary DC, the investigators want biomechanically analyze its function in pathological situation. The physiology of this muscle is richly documented in healthy subjects. But does this knowledge apply in DC? Acquisition of imagery by the "Cone Beam" or CBCT system (Cone Beam Computed Tomography) before and 5 weeks after the injection of BoNT, will allow the analysis of the displacement of each vertebrate.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Patients between the ages of 18 and 70
  • Presenting with a diagnosed focal CD with predominantly rotational by a neurologist specialized in abnormal movements
  • Receiving botulinum toxin injection at OIC level as part of his treatment
  • Express consent to participate in the study
  • Member of or beneficiary of a social security scheme

排除标准

  • Mobile DC (scrapie and/or myoclonic) that cannot be controlled the recording time by the CBCT system
  • Having already benefited from an injection of BoNT as part of their DC in the last three months
  • Inability to sit still
  • Neurological condition other than DC (parkinsonian syndrome typical or atypical, others.)
  • Severe neck pain
  • Known or suspected trauma or pathology of the cervical spine, other than DC, having required treatment in the last 6 month
  • Same old surgery of the cervical spine
  • Patient benefiting from a legal protection measure
  • Pregnant or breastfeeding women (a urine pregnancy test will be carried out in women under 50)

结局指标

主要结局

Changes in posture and main movement rotation of the cervical spine

时间窗: Before (day0) and after injection of BoNT (after 8 weeks max)

Movement of primary rotation of the cervical spine on CBCT imaging will be described using the symmetry index (SI), based on the difference angular (in degrees) of the active amplitude of right rotation and left

次要结局

未报告次要终点

研究者

申办方类型
Network
责任方
Sponsor

研究点 (1)

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