NCT00321568

Brief 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 18-65 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. ...

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2006

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 4, 2006

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 19, 2011

Completed
Last Updated

July 2, 2017

Status Verified

April 19, 2011

First QC Date

May 3, 2006

Last Update Submit

June 30, 2017

Conditions

Multiple Sclerosis

Keywords

Multiple SclerosisMagnetic ResonanceMRIMagnetic FieldMS

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of MS.
  • Age between 18 and 65.
  • Central nervous system white matter and grey matter focal disease which may mimic MS in its imaging appearance.

You may not qualify if:

  • Pregnancy or breastfeeding, since contrast is harmful in people who are breastfeeding.
  • Unable to provide informed consent.
  • Permanent tattooed makeup (eyeliner, lip, etc) or general tattoos.
  • 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.
  • Cerebral aneurysms clips, shrapnel or other metal imbedded in the 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 eyes.
  • Severe auto accidents in the past with non-certainty that a metal object is still present in the subject's body.
  • Any psychological contraindications for MRI (e.g., suffering from claustrophobia).
  • \. Age between 18 and 65
  • \. Same as for patients.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • BROWNELL B, HUGHES JT. The distribution of plaques in the cerebrum in multiple sclerosis. J Neurol Neurosurg Psychiatry. 1962 Nov;25(4):315-20. doi: 10.1136/jnnp.25.4.315. No abstract available.

    PMID: 14016083BACKGROUND

  • 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. doi: 10.1093/brain/122.1.17.

    PMID: 10050891BACKGROUND

  • 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. doi: 10.1002/ana.1123.

    PMID: 11558796BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Sponsor Type
NIH

Study Record Dates

First Submitted

May 3, 2006

First Posted

May 4, 2006

Study Start

May 1, 2006

Study Completion

April 19, 2011

Last Updated

July 2, 2017

Record last verified: 2011-04-19

Locations

US(1)