Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:06 PM
Ignite Modification Date:
2025-12-24 @ 9:06 PM
NCT ID:
NCT02831504
Eligibility Criteria:
Inclusion Criteria:
Main Inclusion Criteria
1. 18 years of age or over
2. Genetic confirmation of Myotonic Dystrophy Type 1
3. Able to consent and willing to participate throughout the duration of the study.
Additional Inclusion Criteria for MRI study:
1. Aged between 18 and 55 years
2. Ambulant or ambulant-assisted
Additional Inclusion Criteria for sleep study:
1\. Aged between 18 and 55 years
Exclusion Criteria:
Main Exclusion Criteria
1. Inability to give informed consent
2. If the clinician presumes that the patient will not be able to perform any of the motor function tests involved (Six Minute Walk Test, 30 Seconds Sit and Stand Test, Timed 10-Meter Walk Test)
3. Inability to perform the cardiac and pulmonary assessments
Additional Exclusion Criteria for MRI study:
1\. Pacemaker, ICD or non-MRI-compatible prosthetic material.
Additional Exclusion Criteria for sleep study:
1. ventilated patients
2. patients medicated with stimulants, including Modafinil
3. patients medicated with benzodiazepines or antidepressants
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02831504
Study Brief:
Protocol Section:
NCT02831504