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 @ 2:28 AM
Ignite Modification Date:
2025-12-25 @ 2:28 AM
NCT ID:
NCT05764434
Eligibility Criteria:
Inclusion Criteria (patients):
1. 18 years or older
2. neurologist-confirmed possible, probable or definite ALS acc. to El Escorial criteria
3. at baseline: able to lie in an MRI scanner for one hour
Exclusion Criteria (patients):
1. active other neurological or neuromuscular condition explaining the symptoms or a significant part of it
2. other neurological or neuromuscular conditions interfering with the examinations
3. severe cervical spinal stenosis or other relevant disease of the spine or spinal cord that may interfere with study procedures or that may impact the cord segments imaged in this study
4. other severe chronic disease
5. pregnancy
6. general contraindications against MRI scanning (e.g. metal implants, pacemakers)
7. not able to read the patient information due to language barriers (patient information in English and French may be provided)
8. major cognitive deficit impacting the ability to read and understand the patient information and/or to follow the instructions of the study personnel
Inclusion criteria (healthy control persons):
1. 18 years or older
2. able to lie in MRI scanner for one hour
Exclusion criteria (healthy control persons):
1. neurological or neuromuscular conditions
2. other severe chronic disease
3. pregnancy
4. general contraindications against MRI scanning (e.g. metal implants, pacemakers)
5. relevant cervical spinal canal stenosis or other relevant disease of the spine or spinal cord that may interfere with study procedures or that may impact the cord segments imaged in this study
6. not able to read the patient information due to language barriers (patient information in English and French may be provided)
Inclusion criteria (patients with Motor Neuron Diseases other than ALS):
1. 18 years or older
2. neurologist-confirmed Motor Neuron Disease (not ALS)
3. able to lie in MRI scanner for one hour
Exclusion criteria (patients with Motor Neuron Diseases other than ALS):
1. other severe neurologic disease
2. other severe chronic disease
3. pregnancy
4. general contraindications against MRI scanning (e.g. metal implants, pacemakers)
5. relevant cervical spinal canal stenosis or other relevant disease of the spine or spinal cord that may interfere with study procedures or that may impact the cord segments imaged in this study
6. not able to read the patient information due to language barriers (patient information in English and French may be provided)
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
99 Years
Study:
NCT05764434
Study Brief:
Protocol Section:
NCT05764434