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 @ 5:52 PM
Ignite Modification Date:
2025-12-24 @ 5:52 PM
NCT ID:
NCT04806568
Eligibility Criteria:
Inclusion Criteria for people with MS:
* Male/female patients aged 18 to 65 years at screening
* Diagnosis of MS according to the 2017 Revised McDonald criteria
* Disability status at screening with an EDSS score of 0 to 6.5
* Relapsing MS and progressive MS as defined by Lublin
* Neurologically stable within 1 month prior to screening
* Patients receiving the same Disease Modifying Treatment (DMT) for at least 6 months
Exclusion Criteria for people with MS:
* Patients suspected of not being able or willing to cooperate or comply with study protocol requirements
* Patients meeting criteria for other demyelinating diseases of the CNS
* Patients with active chronic disease (or stable but treated with immune therapy) of the immune system other than MS
* Patients with any other significant CNS disease or serious psychiatric disorder which can interfere with the patient's ability to cooperate or comply with the study procedure
* Patients unable or unwilling to undergo MRI scans and EEG
Inclusion Criteria for Healthy Controls:
• Normal hearing and normal or corrected-to-normal vision
Exclusion Criteria for Healthy Controls:
* Any diagnosed neurological, mental, developmental, or psychiatric disorder
* Unrecovered neurological disorders (i.e., stroke, traumatic brain injury)
* Unstable medication within the last 3 months
* Intake of central nervous drugs (e.g., antidepressants)
* Severe physical disorder
* Concurrent participation in another relevant study
* Patients unable or unwilling to undergo EEG measurements
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04806568
Study Brief:
Protocol Section:
NCT04806568