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 @ 4:52 PM
Ignite Modification Date:
2025-12-24 @ 4:52 PM
NCT ID:
NCT04169750
Eligibility Criteria:
Inclusion Criteria:
* age between 18 and 55 years (inclusive);
* cognitive impairment, defined as failure in the SDMT, defined as a corrected score less than 38, i.e. below the 5th percentile of normative value;
* Expanded Disability Status Scale (EDSS) score between 2.0 and 5.5;
* ability to stand upright for at least 180 seconds without any support;
* ability to understand and comply with study requirements;
* ability to provide a valid informed consent before any study procedure.
Exclusion Criteria:
* relapse in the previous 6 months;
* initiation of disease-modifying or symptomatic treatments or physiotherapy programme in the 3 months prior to study entry;
* any medication/physiotherapy changes occurring over the previous 3 months;
* significant visual impairment, defined as a Visual System scoring more than 2 at the Kurtzke Functional Systems Score;
* clinically relevant depression, defined as Beck Depression Inventory-II (BDI-II) score equal or more than 14;
* overt dementia, defined as an adjusted Mini Mental State Examination (MMSE) score equal or less than 24;
* history of epilepsy or seizures;
* any medical condition, including musculoskeletal disorders that can interfere with the study conduction.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT04169750
Study Brief:
Protocol Section:
NCT04169750