Protocol Number: 06-N-0154

Title:

An Exploratory Study on Detection of Cortical and White Matter Damage in Patients with Multiple Sclerosis Using Magnetic Resonance Imaging at 7 Tesla

Number:

06-N-0154

Summary:

This study will evaluate the ability of magnetic resonance imaging (MRI) using different magnet strengths (1.5, 3 and 7 Tesla) to detect damage in different parts of the brain in patients with multiple sclerosis. The higher the Tesla, the greater the ability to see brain changes. Healthy subjects will also be studied to compare findings in patients with those of normal volunteers.

Healthy normal volunteers and patients with multiple sclerosis 18-55 years of age may be eligible for this study. Patients should have minimal clinical disability. Candidates are screened with a medical history, physical examination, and blood and urine tests.

Participants undergo three MRI examinations. The first is on a 1.5 Tesla machine. The second and third - at 3 Tesla and 7 Tesla - are done within 30 days of the first. Each procedure takes about 2 hours. Before and after the 7 Tesla examination, subjects have an electrocardiogram (EKG), their blood pressure and temperature are measured and a blood sample is drawn.

MRI uses a magnetic field and radio waves to produce images of body tissues and organs. This test has several advantages over x-ray methods, such as the ability to see more clearly inside the brain and to see chemical changes that might occur in specific neurological diseases. Also, since x-rays are not used, there is no radiation risk. Radio waves are generated and changes in magnetic fields are measured and analyzed by computer. For the procedure, the subject lies on a table that is moved into a metal cylinder (the MRI scanner) that has a strong magnetic field. Earplugs are worn to muffle loud thumping noises caused by the electrical switching of the radio frequency circuits. During the MRI, subjects receive an injection of a contrast agent called Gadolinium, which brightens the images.

Sponsoring Institute:

National Institute of Neurological Disorders and Stroke (NINDS)

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria:

INCLUSION CRITERIA:

1. Diagnosis of MS.

2. Age between 18 and 55.

3. Central nervous system white matter and grey matter focal disease which may mimic MS in its imaging appearance.

EXCLUSION CRITERIA:

1. Serious medical condition like any of the following medical conditions: diabetes mellitus, heart disease (angina, arrhythmias, congestive heart failure), chronic obstructive pulmonary disease, autonomic disorders, sweating or perspiration disorders, hearing disorders. All this will be assessed at the time when the medical history will be collected.

2. Pregnancy or breastfeeding since contrast is harmful in people who are breastfeeding.

3. Unable to provide informed consent.

4. Permanent tattooed makeup (eyeliner, lip, etc) or general tattoos.

5. 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), any metallic implants or objects, body piercing(s), bone/joint pin, screw, nail, plate, wire sutures or surgical staples, shunt.

6. Cerebral aneurysm clips, shrapnel or other metal imbedded in your body (such as from war wounds or accidents).

7. Previous work in metal fields or with machines that may have left any metallic fragments in or near your eyes.

8. Severe auto accidents in the past with non-certainty that a metal object is still present in the subject's body.

9. Any psychological contraindications for MRI (e.g., suffer from claustrophobia).

10. A condition known to change normal body temperature (e.g., thyroid disease, adrenal disease, and peri-menopausal women who have hot flashes).

11. Medications that have the possibility of altering vital signs and ability to control body temperature (such as beta blockers).

Special Instructions:

Currently Not Provided

Keywords:

Multiple Sclerosis

Magnetic Resonance

MRI

Magnetic Field

Recruitment Keyword(s):

Multiple Sclerosis

MS

Condition(s):

Multiple Sclerosis

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

None

Supporting Site:

National Institute of Neurological Disorders and Stroke

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Brownell B, Hughes JT. The distribution of plaques in the cerebrum in multiple sclerosis. J Neurol Neurosurg Psychiatry. 1962 Nov;25:315-20.

Kidd D, Barkhof F, McConnell R, Algra PR, Allen IV, Revesz T. Cortical lesions in multiple sclerosis. Brain. 1999 Jan;122 ( Pt 1):17-26. PMID: 10050891

Peterson JW, Bo L, Mork S, Chang A, Trapp BD. Transected neurites, apoptotic neurons, and reduced inflammation in cortical multiple sclerosis lesions. Ann Neurol. 2001 Sep;50(3):389-400.

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department of Clinical Research Informatics, CC.

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