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 @ 9:57 PM
Ignite Modification Date:
2025-12-24 @ 9:57 PM
NCT ID:
NCT00786032
Eligibility Criteria:
Inclusion and Exclusion Criteria
1. Subject will be a veteran with El Escorial "Lab Supported Probable" or more definite diagnosis of ALS.
2. Subject will have lost the ability to communicate either verbally or in writing (item 1 or item 4 on the ALS Functional Rating Scale-Revised (ALSFRS-R) score of 0, Appendix A) .
3. Subject will be an adult (age \>18).
4. Subject will be living at home.
5. Subject will be living within 100 miles of the participating study site.
6. Subject will have corrected visual acuity of at least 20/80.
7. Subject will have the ability to read and understand 6th grade English text on a computer screen.
8. Subject will be able to indicate willingness and understanding of the consent form (using their existing method of communication).
9. Subject will be able to identify one significant other.
10. Subject will identify one system operator (person that agrees to be trained and set up the BCI). This person can be the significant other.
11. Subject will be able to communicate non-verbally with their significant other, caregiver and system operator, and with study personnel.
12. Significant other, caregiver and system operator will be able to indicate willingness and understanding of the consent form, be adults (age\> 18) and expect to be with the subject for at least one year.
13. Subject, significant other, caregiver and system operator will have life expectancy of at least one year.
14. In the opinion of the BCI installation team, the home environment is physically and technologically conducive to BCI operation and use.
15. Subject will demonstrate during the screening phase sufficient EEG interaction for the BCI to operate, i.e. classification rate of 70%. Classification rate is defined as the proportion of correct selections made during the daily calibration period of "copy spelling." Copy spelling data refers to data collected while the patient attends to and selects specific predefined characters.
16. Significant other, caregiver and system operator will demonstrate during the screening phase sufficient skill to manage the daily set-up and routine operations needed for the subject's basic operation of the BCI.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
79 Years
Study:
NCT00786032
Study Brief:
Protocol Section:
NCT00786032