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临床试验/NCT06574919
NCT06574919招募中不适用

Clinical and Functional Assessment of Patients With Inherited Non-Duchenne Myopathies in Sohag University Hospital

Sohag University3 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
3
主要终点
Clinical and Functional Assessment of patients with Inherited Non-Duchenne Myopathies in Sohag University Hospital

研究概览

简要总结

Muscular Myopathies are a heterogenous group of inherited muscular disorders characterized by progressive muscle weakness. Historically, these disorders are difficult to treat. In the last three decades, there is a great progress in molecular and genetic basis of these disorders; early diagnosis is achievable with proper clinical recognition and advanced genetic testing [1].

Duchenne Muscular Dystrophy (DMD) is a neuromuscular muscular X-linked recessive disorders that belong to a group of disorders known as dystrophinopathies. DMD is caused by mutations in the dystrophin gene that placed in the middle of short arm of X chromosome [2]. Mutation in this gene lead to absence of dystrophin or structural defects of this protein. The lack of functional dystrophin impairs the structure and function of myofibers which are essential for physiological growth of muscle tissue [3].

The non-dystrophic myopathies are a group of inherited myopathies defined by distinctive static histochemical and/or characteristic ultrastructural changes on muscle.

The nomenclature of dystrophic myopathies can be confusing as some of them are classified by age of onset of symptoms (e.g., congenital muscular dystrophies), whereas others are classified by distribution of weakness (e.g., limb-girdle muscular dystrophies, distal myopathies, facioscapulohumeral dystrophy, and oculopharyngeal muscular dystrophy), by characteristic clinical features (e.g., myotonic dystrophy), by the name of the causative gene (e.g., GNE-myopathy, dystrophinopathies), whereas others are named after the physician first describing the disease (i.e., Duchenne and Becker muscular dystrophy or Bethlem myopathy) or can be subdivided in an entirely different way (i.e., the subgroups of the limb-girdle muscular dystrophies which were named according to their mode of inheritance and order of publication) ]4[ Several aspects need to be taken into account in order to establish a clinical diagnosis; these features include but are not limited to the severity of the muscular wasting, as well as its distribution, and the accompanying symptomology, biochemical, hematological, physical, and neurological investigations, electromyography, and muscle biopsy. Moreover, if the gene defect is established, diagnosis can also be confirmed by gene testing ]5[

Muscle biopsy lacks of typical dystrophic features such as increased conjunctive endomysial tissue, necrosis, and regeneration and shows one or more characteristic histological features. Based in pathological descriptions, the main non-dystrophic myopathies were described during the last century, taking into account the age of onset and the structural or ultrastructural markers [6].

Certain genes, in particular those with large sizes (TTN, RYR1, NEB), may present with different clinical and histological phenotypes and therefore their related myopathies be classified within different groups [7].

It is useful to know that other genetic myopathies may mimic non-dystrophic myopathies. This is the case of certain metabolic and mitochondrial myopathies that may show very selective muscle weakness. The description of these disorders goes beyond the scope of this chapter. However, it may be useful to take into account at least three examples, Pompe disease, the glycogen storage disorder type II (GSD II), and TK2-related mitochondrial DNA depletion myopathy, because they may present as congenital or later-onset non-dystrophic myopathies, may show particular muscle imaging abnormalities, and may be treatable [8; 9].

Understanding the clinical and molecular characteristics of non-DMD is crucial for several reasons. First, accurate diagnosis is essential for proper genetic counseling and family planning. Second, identification of the specific genetic mutation allows for the potential development of targeted therapies in the future. Finally, characterization of the clinical course of different non-DMD can guide treatment decisions and improve patient outcomes.

详细描述

Type of the study:

This study will be a prospective, observational study

Place of the study:

Pediatric Neurology Clinic and Genetics Unit, Department of pediatrics, Sohag University Hospital. , Sohag, Egypt.

Study duration:

研究设计

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

入排标准

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

入选标准

  • • Age between 2 and 18 years
  • Confirmed diagnosis of non-DMD based on clinical features, laboratory investigations, and genetic testing.
  • Patients and their parents agree to participate in the study.

排除标准

  • • Children with a confirmed diagnosis of DMD
  • Children with incomplete medical records or unavailable clinical data.
  • Children with endocrinal ,nutritional critical care and inflammatory myopathies.
  • Other neuromuscular disorders that affect AHC or nerves as SMA, congenital myasthenia Gravis and neuropathic.
  • Other acquired neuromuscular disorders as Guillain Barre syndrome and toxic myopathy.
  • Patients and their parents refuse to participate in the study.

结局指标

主要结局

Clinical and Functional Assessment of patients with Inherited Non-Duchenne Myopathies in Sohag University Hospital

时间窗: 1 year

Characterize the clinical, laboratory, radiological, electrophysiological and molecular features of patients with non-Duchenne muscular dystrophies

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marwa Nasser Abdelaal

Resident-pediatric department-sohag hospital university

Sohag University

研究点 (3)

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