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

NCT00393588 | Completed

• 2 other identifiers: 07001407-N-0014
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test the ability of magnetic resonance imaging (MRI) to detect damage in different parts of the brain in patients with multiple sclerosis and to see if cognitive problems in patients can be correlated with the presence of lesions or reduction in the size of certain part of the brain. Healthy subjects will also be studied to compare findings in patients with those of normal volunteers. Healthy subjects and patients with multiple sclerosis who are between 18 and 60 years of age may be eligible for this study. Patients must not have severe clinical disability and must have been receiving and responding to Interferon beta for at least 6 months prior to enrollment. Candidates are screened with a medical history, physical examination, MRI and possibly evoked potential testing, which measures the nervous system response to visual, auditory and somatosensory stimulation. Participants have two MRI scans within 1 week (inclusive of the one performed for screening). MRI uses a magnetic field and radio waves to obtain images of body tissues and organs. The scanner is a metal cylinder surrounded by a strong magnetic field. During the MRI, the subject lies on a table that can slide in and out of the cylinder. Participants will be tested with magnet strengths of 1.5 and 3 Tesla; the higher the Tesla, the greater the ability to see brain changes. Each scan may last up to 90 minutes. In addition to the MRI scans, participants undergo cognitive testing that measures memory and thought processes and complete forms that test and quantify fatigue level, stress, anxiety and depression

Conditions

Multiple Sclerosis

Keywords

Brain; Cognitive Deficits; Cognitive Testing; MRI; Multiple Sclerosis; MS; Healthy Volunteer; HV

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National Institute of Neurological Disorders and Stroke (NINDS): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• Noseworthy JH, Lucchinetti C, Rodriguez M, Weinshenker BG. Multiple sclerosis. N Engl J Med. 2000 Sep 28;343(13):938-52. doi: 10.1056/NEJM200009283431307. No abstract available.

  PMID: 11006371 BACKGROUND

• Pugliatti M, Rosati G, Carton H, Riise T, Drulovic J, Vecsei L, Milanov I. The epidemiology of multiple sclerosis in Europe. Eur J Neurol. 2006 Jul;13(7):700-22. doi: 10.1111/j.1468-1331.2006.01342.x.

  PMID: 16834700 BACKGROUND

• Sospedra M, Martin R. Immunology of multiple sclerosis. Annu Rev Immunol. 2005;23:683-747. doi: 10.1146/annurev.immunol.23.021704.115707.

  PMID: 15771584 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis; Cognition Disorders

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Neurocognitive Disorders; Mental Disorders

Study Design

• Study Type: observational
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 27, 2006
• First Posted: October 30, 2006
• Study Start: October 26, 2006
• Study Completion: September 29, 2011
• Last Updated: July 2, 2017

Record last verified: 2011-09-29

Locations

US (1)