Myotonia and Muscle Stiffness in NMD

study id #: NCT04411732

condition: Neuromuscular Disorders

status: Recruiting

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.

intervention: MyotonPro, Six-minute walk test, Semiquantitative muscle ultrasound, Hand-held Dynamometry of muscle strength

results: https://clinicaltrials.gov/ct2/show/results/NCT04411732

last updated: February 04, 2022

start date: October 1, 2019

estimated completion: March 31, 2023

last updated: February 8, 2021

size / enrollment: 90

primary outcomes:

• MyotonPro device in patients with dystrophic and non-dystrophic myotonia
  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.
• 1 day
  

secondary outcomes:

• MyotonPro device - reference values in patients with dystrophic and non-dystrophic myotonia
  1 day
• MyotonPro device - reference values in patients with non-myotonic neuromuscular disorders
  1 day
• MyotonPro device - correlations between stiffness, muscle tone, relaxation periods and elasticity with clinical muscle function tests
  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 - correlations between stiffness, muscle tone, relaxation periods and elasticity and the 6-minute-walk test
  1 day

inclusion criteria:

exclusion criteria: 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

sponsor: LMU Klinikum

contacts: Stephan Wenninger, Dr. Med., +49 89440057470, stephan.wenninger@med.uni-muenchen.de

investigators: Stephan Wenninger, Dr. Med.,Neurologist

trial center locations: Germany

• Myotonia and Muscle Stiffness in NMD
  Benedikt Schoser, MD, +4989440057470, bschoser@med.uni-muenchen.de