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:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
NCT ID:
NCT06137612
Eligibility Criteria:
Inclusion Criteria (patients)
1. 11 years or older
2. Informed consent by the participants or, in children below the age of legal consent, by a legally authorized representative
3. genetically confirmed diagnosis of 5q-SMA (Types II or III)
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. other severe chronic disease
4. pregnancy
5. general contraindications against MRI scanning (e.g. pacemakers)
6. not able to understand the patient information due to language barriers
7. In the event of a participant incapable of judgment, symptoms showing that the participant is unwilling to participate in the study will result in the participant being excluded from participation
Inclusion Criteria (healthy volunteers)
1. participants will be selected to be age-and sex-matched to the patients
2. 11 years or older
3. Informed consent by the participants or, in children below the age of legal consent, by a legally authorized representative
Exclusion Criteria (healthy volunteers):
1. active neurological or neuromuscular condition
2. other neurological or neuromuscular conditions interfering with the examinations
3. other severe chronic disease
4. pregnancy
5. general contraindications against MRI scanning (e.g. pacemakers)
6. not able to understand the patient information due to language barriers
7. In the event of a participant incapable of judgment, symptoms showing that the participant is unwilling to participate in the study will result in the participant being excluded from participation
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
11 Years
Study:
NCT06137612
Study Brief:
Protocol Section:
NCT06137612