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:
2025-12-25 @ 4:04 AM
Ignite Modification Date:
2025-12-25 @ 4:04 AM
NCT ID:
NCT07257302
Eligibility Criteria:
Inclusion Criteria:
* Age 20 years or older
* Diagnosis of amyotrophic lateral sclerosis (ALS) according to the El Escorial or Awaji criteria
* Not using noninvasive ventilation (NIV) and without tracheostomy at the start of LIC training
* Able to perform study assessments and provide written informed consent (or assisted signature with communication aid)
Exclusion Criteria:
* Chronic pulmonary disease other than ALS (e.g., COPD, interstitial lung disease)
* Severe cognitive or communication impairment preventing study participation
* Uncontrolled cardiovascular disease, including unstable angina, recent myocardial infarction, decompensated heart failure, serious arrhythmia, severe aortic stenosis, or active myocarditis/endocarditis
* Uncontrolled hypertension
* Acute systemic illness or fever
* Recent pulmonary embolism, acute cor pulmonale, or severe pulmonary hypertension
* Severe hepatic or renal dysfunction
* Any condition judged inappropriate by the investigator
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Study:
NCT07257302
Study Brief:
Protocol Section:
NCT07257302