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 @ 5:23 PM
Ignite Modification Date:
2025-12-24 @ 5:23 PM
NCT ID:
NCT06569550
Eligibility Criteria:
Inclusion Criteria:
* A confirmed diagnosis of relapse-remitting multiple sclerosis, according to most recent McDonald's criteria (Thompson et al., 2018). This diagnosis must not be more recent than 3 months
* Must have fatigue as a complaint, and an FSMC score corresponding to at least moderate fatigue (\>53)
* Stable MS medication for at least 3 months
Exclusion Criteria:
* Pregnancy, any subject with the potential to become pregnant must ensure against this (e.g. by taking oral contraceptives, or other high efficacy method)
* MS Relapse or steroid treatment within 3 months prior to inclusion
* Current treatment targeted towards fatigue, or previous if discontinued within 3 months prior to inclusion
* History of neurologic disease or other significant medical conditions, aside from MS
* EDSS \> 6.5
* Major psychiatric disorder, including current clinical depression
* Pacemaker or other implanted electronic devices
* Any intracranial metal
* Any metallic implant incompatible with MR scanning
* Claustrophobia
* Either patient or their close relatives suffering from epilepsy
* Current Drug or alcohol abuse
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT06569550
Study Brief:
Protocol Section:
NCT06569550