Magnetic Resonance Imaging to Detect Brain Damage in Patients With Multiple Sclerosis

This is an observational trial for Multiple Sclerosis focused on measuring Brain, Cognitive Deficits, Cognitive Testing, MRI, Multiple Sclerosis, MS, Healthy Volunteer, HV Read More

• PATIENT INCLUSION CRITERIA:
• Diagnosis of relapsing remitting or secondary progressive with superimposed relapses MS.
• Age between 18 and 60, inclusive.
• EDSS between 0 and 6.5.
• Receiving treatment with Interferon beta (either 1a or 1b) at fully tolerated dose for at least 6 months prior to enrollment and with evidence of clinical efficacy (i.e. reduction or absence of clinical relapses) at the time of the enrollment.

PATIENT EXCLUSION CRITERIA:

• Clinical relapse at the time of the enrollment or within the previous 3 months.
• Undergoing chronic therapy with any other immunomodulatory or immunosuppressive medication (excluding standard dosages of steroids intravenously/intramuscularly injected and orally taken for the treatment of relapses) besides Interferon within the past 6 months.
• Currently taking medications used for treatment of cognition/fatigue such as Donepezil (Aricept), Modafinil (Provigil), Amantadine, or other drugs that may act as temporary stimulants or depressants for the central nervous system.
• Currently taking other medications used for symptomatic relief that may affect cognition. The study neurologist will make the determination of eligibility.
• Clinically significant medical condition that, in the opinion of the investigator, would compromise patient's safety or affect his/her MRI (e.g., diabetes mellitus, chronic hypertension, severe anemia, kidney disease, heart disease [angina, arrhythmias, congestive heart failure]).
• Pregnancy or current breastfeeding.
• Previous eye surgery of any kind.
• Inability to provide informed consent. The ability of the patients in understanding all the aspects of the protocol will be judged by the means of a questionnaire.
• Permanent tattooed makeup (eyeliner, lip, etc.) or general tattoos. Subjects with tattoos will be excluded if those are in a dangerous location in the body or made with colors whose content in iron (e.g. dark blue or dark green) cannot be definitely ruled out by the Investigators.
• Any non-organic implant or any other device such as: cardiac pacemaker, insulin infusion pump, implanted drug infusion device, cochlear, otologic, or ear implant, transdermal medication patch (nitro, hormones) that may cause problems if removed, even temporarily, any metallic implants or objects, body piercing(s), bone/joint pin, screw, nail, plate, wire sutures or surgical staples, shunt.
• Cerebral or other aneurysm clips.
• Shrapnel or other metal imbedded in the patient's body (such as from war wounds or accidents).
• Previous work in metal fields or with machines that may have left any metallic fragments in or near patients' eyes.
• A severe auto accident in the past if it is uncertain that any metal may still be imbedded in the patient's body.
• Any psychological contraindications for MRI (e.g., suffer from claustrophobia). This will be assessed at the time when the medical history will be collected.
• Any contraindications to having study procedures done.

HEALTHY VOLUNTEER INCLUSION CRITERIA:

• Age between 18 and 60.
• Vital signs are found within the normal range at the time of the screening visit.

HEALTHY VOLUNTEER EXCLUSION CRITERIA:

• Clinically significant medical condition that, in the opinion of the investigator, would compromise the patient's safety or affect his/her MRI (e.g., diabetes mellitus, chronic hypertension, severe anemia, kidney disease, heart disease [angina, arrhythmias, congestive heart failure]).
• Pregnancy.
• Previous eye surgery of any kind.
• Inability to provide informed consent.
• Permanent tattooed makeup (eyeliner, lip, etc) or general tattoos. Subjects with tattoos will be excluded if those are in a dangerous location in the body or made with colors (e.g. dark blue and dark green) whose content in iron cannot be definitely ruled out by the Investigators.
• Any non-organic implant or any other device such as: cardiac pacemaker, insulin infusion pump, implanted drug infusion device, cochlear, otologic, or ear implant, transdermal medication patch (Nitro, hormones) that may cause problems if removed even temporarily, any metallic implants or objects, body piercing(s), bone/joint pin, screw, nail, plate, wire sutures or surgical staples, shunt.
• Cerebral or other aneurysm clips.
• Shrapnel or other metal imbedded in the subject's body (such as from war wounds or accidents).
• Previous work in metal fields or with machines that may have left any metallic fragments in or near the subject's eyes.
• A severe auto accident in the past so if it is uncertain whether any metal may still be imbedded in the subject's body.
• Any psychological contraindications for MRI (e.g., suffer from claustrophobia). This will be assessed at the time when the medical history will be collected.
• Any contraindications to having study procedures done.