Myotonia, Muscle Stiffness and Elasticity in Neuromuscular Disorders
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Neuromuscular Disorders
- Sponsor
- LMU Klinikum
- Enrollment
- 133
- Locations
- 1
- Primary Endpoint
- MyotonPro device in patients with dystrophic and non-dystrophic myotonia
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
The primary objective of this study is to assess stiffness, muscle tone, relaxation periods and elasticity of various muscles in patients with dystrophic or non-dystrophic myotonia. The secondary objectives are (1) to provide reference values for stiffness, muscle tone, relaxation periods and elasticity of various muscles in patients with dystrophic or non-dystrophic myotonia; to provide reference values for stiffness, muscle tone, relaxation periods and elasticity of various muscles in patients with non-myotonic neuromuscular disorders, (3) assess correlations between to compare result values for stiffness, muscle tone, relaxation periods and elasticity with clinical muscle function tests, measured by clinical evaluation (MRC-scale) and the 6-minute walk test; (4) assess correlations between subcutaneous fat and muscle thickness and echogenicity, measured by muscle ultrasound and result values for stiffness, muscle tone, relaxation periods and elasticity.
Investigators
Prof. Dr. Benedikt Schoser
Prof. Dr. med. Benedikt Schoser
LMU Klinikum
Eligibility Criteria
Inclusion Criteria
- •For Patients:
- •≥18 years of age
- •Confirmed neuromuscular disease
- •written consent
- •able and willing to perform study prodcedures
- •For healthy volunteers:
- •age ≥18 years of age
- •written informed consent
- •no clinical sign for neuromuscular disorders
Exclusion Criteria
- •Severe comorbidities
- •Patient is participating in another clinical study using investigational treatment
- •Patient cannot perform required muscle function tests
- •the patient, in the opinion of the investigator, is unable to adhere to the requirements of the study
Outcomes
Primary Outcomes
MyotonPro device in patients with dystrophic and non-dystrophic myotonia
Time Frame: 1 day
The primary objective of this study is the comparison of viscoelastic stiffness of the underlying tissue measured by stiffness (S), elasticity (D) and relaxation (R) between patients with dystrophic and non-dystrophic myotonia.
Secondary Outcomes
- MyotonPro device - reference values in patients with non-myotonic neuromuscular disorders(1 day)
- MyotonPro device - correlations between stiffness, muscle tone, relaxation periods and elasticity and the 6-minute-walk test(1 day)
- MyotonPro device - correlations between stiffness, muscle tone, relaxation periods and elasticity with subcutaneous fat and muscle thickness and echogenicity(1 day)
- MyotonPro device - reference values in patients with dystrophic and non-dystrophic myotonia(1 day)
- MyotonPro device - correlations between stiffness, muscle tone, relaxation periods and elasticity with clinical muscle function tests(1 day)