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:
2025-12-25 @ 2:48 AM
Ignite Modification Date:
2025-12-25 @ 2:48 AM
NCT ID:
NCT04033133
Eligibility Criteria:
Inclusion Criteria:
* Confirmed diagnosis of multiple sclerosis by a neurologist
* No change in MS-specific medication (disease modification drugs) in the last three months
* Healthy enough to complete the protocol based on information obtained from a clinical exam and past medical history.
* An expanded disability status scale (EDSS) below 5.5
* Comprehension of the protocol as indicated by an ability to respond to questions about the study after reading the consent form.
* Able to use and be contacted by telephone
* Able to speak, read, and understand English, and complete a questionnaire in English
* Body mass index \<30 kg/m2
Exclusion Criteria:
* A relapse of disease symptoms in the last three months
* History / presence of secondary conditions such as seizure disorders (or on medications known to lower seizure threshold), hydrocephalus, diabetes mellitus, or claustrophobia
* Alcohol dependence or abuse (\>2 drinks/day), or present history (last six months) of drug abuse
* History of significant traumatic brain injury or hydrocephalus
* Currently pregnant
* Recent hospitalization (within the last 3 months) or enforced bed rest/sedentary state
* Claustrophobia
A subject will be excluded if he/she has a contraindication to Magnetic Resonance scanning, e.g., implanted metal clips or wires, which may concentrate radiofrequency fields or cause tissue damage from twisting in a magnetic field.
Examples include:
* Aneurysm clip
* Implanted neural stimulator
* Implanted cardiac pacemaker or autodefibrillator
* Cochlear implant
* Ocular foreign body (e.g., metal shavings)
* Any implanted device (pumps, infusion devices, etc.)
* Shrapnel injuries
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT04033133
Study Brief:
Protocol Section:
NCT04033133