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 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07454733
Eligibility Criteria:
Inclusion Criteria for People with ALS:
* Diagnosis of ALS by either El- Escorial or Gold Coast Criteria
* ≥18 years of age
* Plan to attend MDC visits for 12 months
* Speak English or Spanish
* Presence of a caregiver (defined as someone who assists with care) who is also participating in the VITALS trial
* Projected life expectancy of at least 12 months as determined by the site investigator.
Exclusion Criteria for People with ALS:
* Unable or unwilling to provide informed consent or follow study procedures
* Significant cognitive impairment, clinical dementia, or unstable psychiatric illness (including, but not limited to, psychosis, active suicidal ideation, suicide attempt, or untreated major depression) as determined by the site investigator
* Current pregnancy based on participant self-report;
* Unable to access the internet;
* Do not have access to a personal or shared email and are not interested in creating a personal or shared email;
* Do not wish to create a patient portal account, if they do not already have one;
* Uncorrected hearing or visual impairment that would impair the ability to view video recordings;
* Incarcerated.
Inclusion Criteria for Caregivers:
* Agree to their identified role as a caregiver of a patient with ALS participating in the VITALS trial;
* Speak English or Spanish;
* ≥18 years of age.
Exclusion Criteria for Caregivers:
* Unable or unwilling to provide consent or follow study procedures;
* Unable to access the internet;
* Do not have access to a personal or shared email and are not interested in creating a personal or shared email;
* Uncorrected hearing or visual impairment;
* Professional caregiver for the patient;
* Incarcerated.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07454733
Study Brief:
Protocol Section:
NCT07454733