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 @ 11:35 PM
Ignite Modification Date:
2025-12-24 @ 11:35 PM
NCT ID:
NCT03723356
Eligibility Criteria:
Inclusion Criteria:
1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
2. Male and Female subjects between 18 and 45 years
3. WRAT-4 Reading \[127\] standard score \> 85
4. Able to undergo neuroimaging data collection procedures. For MS Participants
5. Definite diagnosis of RRMS \[128\]
6. EDSS of 0 to 6.0
7. Adequate vision as as reported by the participant (with correction if applicable)
8. Clinically prescribed Tecfidera, Tysabri or Ocrevus therapy by treating neurologist, with first dose being within 3 months + 14 days from baseline visit
9. At baseline visit, concurrent medications to be kept constant over three months prior to data collection visits
10. No relapse or steroids in previous month
Exclusion Criteria:
1. Unable or unwilling to provide informed consent.
2. Beck Depression Inventory-Fast Screen (BDI-FS) \[129, 130\] score of 4 or more
3. Current alcohol or other substance use disorder
4. Primary psychiatric disorder that would adversely influence ability to participate
5. Other neurological condition associated with cognitive impairment (e.g., epilepsy, brain injury)
6. Other serious uncontrolled medical condition (e.g., cancer or acute myocardial infarction)
7. Learned English language after 12 years of age
8. For low absolute low lymphocyte count (ALC), USPI guidance will be utilized.
For MS participants:
9. Lemtrada, Cladribine, Mitoxantrone
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT03723356
Study Brief:
Protocol Section:
NCT03723356