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 @ 9:45 PM
Ignite Modification Date:
2025-12-24 @ 9:45 PM
NCT ID:
NCT06491732
Eligibility Criteria:
Inclusion Criteria:
* Sporadic or familial ALS diagnosed as clinically possible, probable, lab-supported probable, or definite ALS defined by revised El Escorial criteria
* Capable of providing informed consent and complying with study procedures in the investigator's opinion
* Time since ALS symptom onset ≤36 months
* Vital Capacity of ≥50% of predicted capacity as measured by forced vital capacity
* Must have a study partner for home visits
* Access to the internet for data upload
* Age 18 years or older
Exclusion Criteria:
* Clinically significant unstable medical condition (other than ALS) that would affect the participant's ability to participate, according to the investigator's judgment
* Patient with pure upper motor neuron disease (PLS)
* Known history of unstable psychiatric disease, cognitive impairment, dementia, or active substance abuse
* Significant pitting edema (2+ or more) that would interfere with EIM measures
* Active cancer or history of cancer treated with chemotherapy and/or radiation
* BMI \>35
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06491732
Study Brief:
Protocol Section:
NCT06491732