Viewing Study NCT04799366



Ignite Creation Date: 2024-05-06 @ 3:54 PM
Last Modification Date: 2024-10-26 @ 1:59 PM
Study NCT ID: NCT04799366
Status: COMPLETED
Last Update Posted: 2023-03-30
First Post: 2021-03-11

Brief Title: Contractile Properties of Hypertrofic Muscles in Patients With Non-Dystrophic Myotonia
Sponsor: Rigshospitalet Denmark
Organization: Rigshospitalet Denmark

Study Overview

Official Title: Contractile Properties of Hypertrofic Muscles in Patients With Non-Dystrophic Myotonia
Status: COMPLETED
Status Verified Date: 2023-03
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: In myotonia congenita MC mutations in the CLCN1 gene coding a key chloride channel expressed in muscle cells cause myotonia On examination the myotonia can be demonstrated as delayed muscle relaxation of muscle contractions after mechanical stimulations Existing literature describe no muscle weakness in MC patients however a recent muscle MRI study in non-dystrophic myotonia patients found structural abnormalities in affected muscles when examined using T1 and STIR imaging The question remains whether the signs of structural changes in the muscle are merely due to the myotonia or long-term effects of elevated stress of the tissue and if so whether those changes lead to clinically significant loss of contractile properties of the muscle

This study examines if the contractile properties of myotonic muscles are impaired in MC patients 40 patients with Thomsens disease n20 and Beckers disease n20 respectively will be included along with 20 healthy controls Peak muscle torque is measured in the hand by hand dynamometer and in the thigh and calf muscles with a Biodex System 4 Pro Dynamometer and the cross-sectional area of the muscles are examined on T1-weighed and Dixon-MRI-scan With the obtained data peak torque in strength tests muscle hypertrophy fat fraction in muscle tissue and contractility of the muscles compared with healthy controls will be assessed
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None