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 @ 11:08 PM
Ignite Modification Date:
2025-12-24 @ 11:08 PM
NCT ID:
NCT06834269
Eligibility Criteria:
Inclusion Criteria:
* age ≥ 18
* diagnosis of possible, probable or definite ALS according to revised El Escorial criteria and Awaji-Shima criteria
* disease duration \< 24 months
* ALSFRS-R \> 30 at the recruitment
* ALSFRS-R decline \> 1 in the at least 3-months period before the intervention
* normal respiratory functionality at the preliminary evaluation (M-3), assessed in the previous month (FVC ≥ 75% and ALSFRS-R items 10,11,12 \> 4)
* treatment with riluzole 50 mg x 2/die
Exclusion Criteria:
* inclusion in other clinical trials
* presence of tracheotomy or/and PEG (percutaneous endoscopic gastrostomy)
* unable to perform spirometry due to severe bulbar involvement
* contraindications to magnetic fields exposure
* pregnancy or breastfeeding
* history of epilepsy or seizures
* use of drugs acting on central nervous system, except for antidepressive drugs and benzodiazepines.
* cognitive impairment
* lack of informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06834269
Study Brief:
Protocol Section:
NCT06834269