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 @ 10:14 PM
Ignite Modification Date:
2025-12-24 @ 10:14 PM
NCT ID:
NCT04702035
Eligibility Criteria:
Age limits for the NPH patient group and the matched healthy vonunteers group are 60-100 years.
Age limits for the young healthy volunteers group are 18-40 years.
Inclusion Criteria:
NPH patient group:
1. Informed Consent as documented by signature prior to any study related procedures or informed consent by a legal representative in case of cognitive deficits.
2. Male and female patients alike
3. Age between 60 and 100 years
4. Clinical suspect for NPH
5. Significant improvement (by more than 10%) in walking speed or endurance in a standardized CSF-TAP test (of at least 35 ml CSF).
6. Planned implantation of a VP shunt for NPH treatment (independently from the study).
Matched controls group:
1. Informed Consent as documented by signature prior to any study related procedures
2. Male and female patients alike (matched to group 1)
3. Age between 60 and 100 years (matched to group 1)
4. No clinical suspect for NPH or any other movement disorder
Young controls group:
1. Informed Consent as documented by signature prior to any study related procedures
2. Male and female patients alike (matched to group 1)
3. Age between 18 and 40 years
4. No clinical suspect for NPH or any other movement disorder
Exclusion Criteria:
1. Enrolment of the investigator, his/her family members, employees and other dependent persons (only for patients; no exclusion criteria for controls),
2. Apparent or suspected movement disorder or other known disorder, which might affect normal standing or walking
3. Cardiovascular disorders, which might affect physical resilience
4. Pregnant women
5. Pre-menopausal state of female patients and probands in groups 1 and 2.
6. Children and adolescents
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT04702035
Study Brief:
Protocol Section:
NCT04702035