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 @ 5:18 PM
Ignite Modification Date:
2025-12-24 @ 5:18 PM
NCT ID:
NCT07086950
Eligibility Criteria:
Inclusion Criteria:
1. Informed Consent signed by the participant,
2. Adults 18+ years,
3. Patients with a diagnosis of relapsing multiple sclerosis according to the most recent internationally recognized criteria, as evaluated by their treating physicians (Thompson et al., 2018) or secondary progressive MS (diagnosis ≤ 30 months),
4. Presence of cognitive complaint,
5. Z-Score ≤ -0.5 in the Symbol Digit Modalities Test (SDMT)
Exclusion criteria:
1. Clinically or radiologically confirmed MS relapses within 3 months prior to enrollment,
2. Change in disease modifying treatments (DMT), antidepressant or anxiolytic medication within 1 month prior to enrollment,
3. High risk of falls based on a completion time of more than 15 seconds in the Four Square Step Test (FSST) (Dite \& Temple, 2002),
4. Assisted locomotion or falls in the past 3 months as evaluated in the enrollment interview (Hopkins Falls Grading Scale (Grade \> 1)),
5. Major psychiatric and/or neurocognitive disorders according to the DSM-5 (APA, 2013),
6. Incapacity to discriminate colors (Ishihara test; (Clark, 1924)),
7. Insufficient language knowledge to understand instructions or questionnaires,
8. High-risk pregnancy as evaluated by the appointed gynecologist.
9. Z-Score ≤ -3.5 in the Symbol Digit Modalities Test (SDMT).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07086950
Study Brief:
Protocol Section:
NCT07086950