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:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-26 @ 3:20 PM
NCT ID:
NCT07413718
Eligibility Criteria:
Inclusion Criteria:
* Patients diagnosed with spinal ALS
* men and women
* diagnosis date less than two years ago, according to the "El Escorial" criteria (Appendix 2)
* PIM above the lower limit of normal
* Preserved lung function (FVC ≥ 80%, FEV1 ≥ 80%, FEV1/FVC ≥ 80%) and normal values in supine position
Exclusion Criteria:
* Patients with signs of respiratory muscle weakness (MIP and MEP below the LLN and abnormal decubitus tests19-21)
* Nocturnal hypoventilation
* Inability to perform the measurement tests
* Inability to understand and perform the exercises
* Any contraindication to the use of IMT. Severe psychiatric illness.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT07413718
Study Brief:
Protocol Section:
NCT07413718