fMRI Study of Treatment Recommendations Comparing Recently Diagnosed Multiple Sclerosis (MS) Patients to Controls

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

Impaired short term memory, attention and concentration lapses, and slower processing of information occur in up to 40-65% of patients with Multiple Sclerosis (MS). The quality of life of individuals with MS is impacted to the degree with which they experience these symptoms.

There are several medications approved by the United States Food and Drug Administration (FDA) to treat MS symptoms and to modify (slow) disease course. Traditional approaches to determining the effectiveness of medications used in treating MS rely on reports of the number of relapses an individual experiences, as well as standard clinical tests, such as the Kurtzke Expanded Disability Status Scale (EDSS).

This research study will look at whether the functional magnetic resonance imaging (fMRI) scan can be used as a tool for measuring changes in the brain associated with treatment in MS patients. Unlike a typical MRI which provides structural information about the brain, the fMRI provides information about brain activity during performance of cognitive or motor tasks.

• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Waukesha Memorial Hospital
• Collaborator: The Cleveland Clinic

Criteria

Inclusion Criteria MS Subjects:

• Written informed consent and HIPAA authorization.

• Age between 18 and 65 years

• Male and female subjects with clinically definite or laboratory-supported definite relapsing-remitting multiple sclerosis in accordance with the refined McDonald • Diagnosed with Relapsing-Remitting Multiple Sclerosis for ≤ 1 year

• Naive to disease-modifying treatments

• Expanded Disability Status Score (EDSS) of 0 to ≤ 5.5, inclusive

• Willingness and ability to comply with the protocol for the duration of the study

• If female, she must either:

1. be post-menopausal or surgically sterilized; or

2. use a hormonal contraceptive, intra uterine device, diaphragm with spermicide, or condom with spermicide, for the duration of the study; and

3. be neither pregnant nor breast-feeding.

4. confirmation that if the subject can still have children, that she is not pregnant must be established by a negative urine pregnancy test within 30 days of Study Day o.

Exclusion Criteria - MS Subjects:

• Pregnant or lactating women, or women of childbearing potential not using an acceptable method of contraception

• Progressive forms of MS (Primary progressive, Secondary progressive)

• Subjects who have been on DMTs or other previous treatment for MS

• Participation in any other studies involving investigational or marketed products, concomitantly or within 30 days prior to screening

• Treatment with oral or systemic corticosteroids or ACTH within 4 weeks of screening or ongoing chronic treatment with systemic corticosteroids.

• Have taken intravenous immunoglobulin or any other investigational drug or taken part in any experimental procedure in the 6 months prior to screening

• Psychiatric disorder either unstable or would preclude safe participation in the study

• Cognitive impairment which impairs ability to understand or comply with the protocol procedures

• Significant leucopenia (white blood cell count <0.5 times the lower limit of normal) as assessed during the course of routine standard of care

• Elevated liver function tests (ALT, AST, alkaline phosphatase or total bilirubin >2.5 times the upper limit of normal) as assessed during the course of routine standard of care

• Specific systemic diseases, (including insulin-dependent diabetes, Lyme disease, clinically significant cardiac disease, HIV, HTLV-1, and Hepatitis B or C), or other uncontrolled major medical conditions (depression, seizure disorder) that would interfere with the participant's safety, compliance or evaluation

• Unable and/or unlikely to follow the protocol for any reason

• Alcohol and/or any other drug abuse

• Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol.

• Abnormal baseline clinical findings considered by the investigator to be indicative of conditions that might affect study results

• Subjects whose high-resolution anatomic MR scans reveal the presence of a structural abnormality (other than MS)

Specific exclusion criteria are required for MRI scanning:

• Ferrous objects within the body

• Pregnancy

• Weight inappropriate for height

• Low visual acuity that cannot be corrected with glasses

• History of claustrophobia

• Standard protocol for monitoring based on FDA approved medication will be followed