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 @ 12:41 AM
Ignite Modification Date:
2025-12-25 @ 12:41 AM
NCT ID:
NCT03487367
Eligibility Criteria:
Inclusion Criteria:
1. Signed informed consent (no study-related procedures may be performed before the subject has signed the consent form).
2. Subjects of either sex aged 18 to 65 with presence of symptomatic ataxic disease or asymptomatic mutation carrier or
3. Subjects with definite molecular diagnosis of SCA1 or SCA3 or another affected family member
4. Subjects of any age with previous diagnosis of Early stage SCA1 and SCA3
5. Subjects capable of understanding and complying with protocol requirements
6. No changes in physical/occupational therapy status within two months prior to enrollment
Exclusion Criteria:
1. Subjects currently receiving, or having received within 2 months prior to enrollment into this study, any investigational drug.
2. Subjects who do not wish to or cannot comply with study procedures.
3. Genotype consistent with other inherited ataxias
4. Changes in coordinative physical and occupational therapy for ataxia 2 months prior to study participation
5. Concomitant disorder(s) or condition(s) that affects assessment of ataxia or severity of ataxia during this study
6. AIM 2 exclusion criteria also includes the inability to undergo MRI scanning and weight over 300lbs, presence of structural abnormalities such as subdural hematoma or primary or metastatic neoplasms and concurrent illnesses or treatment interfering with cognitive function such as stroke or normal pressure hydrocephalus.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03487367
Study Brief:
Protocol Section:
NCT03487367