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 @ 12:32 AM
Ignite Modification Date:
2025-12-25 @ 12:32 AM
NCT ID:
NCT01640067
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of definite or possible ALS according to revised EL Escorial criteria
* Age: 20-75 years
* documented progression of disease during the last 6 months.
* Absence of concomitant diseases
* Adequate assurances of adherence to protocol
* The patient must be able to communicate verbally or with the use of non-verbal communication system
Group 1
* maximum score of 1 on walking item of ALS functional rating scale
* forced vital capacity \> or equal to 60
Group 2
* forced vital capacity \> or equal to 60
* ambulation difficulties (maximum score of 2 on walking item of ALS functional rating scale)
Group 3
* Independent ambulation (score 4 on a scale ALS-FRS)
* forced vital capacity \> or equal to 70
Exclusion Criteria:
The presence of at least one of the following will lead to patient exclusion.
1. psychiatric diseases or other neurological diseases different from ALS
2. other systemic diseases
3. Neoplasms or other diseases reducing life expectancy
4. Antecedent polio infection
5. corticosteroids, immunoglobulin or immunosuppressive treatment
6. involvement in other clinical trials
7. 2 or more critical items in MMPI
8. neuropsychological evaluation suggestive of mental deterioration or cognitive sphere disturbance.
9. Impediments to MRI
10. patients unable to understand informed consent form and study aims.
11. women who are pregnant or childbearing potential for the duration of the study. Non-pregnant status will be documented by beta-HCG negative test 7 days before treatment start
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
75 Years
Study:
NCT01640067
Study Brief:
Protocol Section:
NCT01640067