MR Perfusion Imaging and Hypercapnia (Increased Carbon Dioxide) to Study New Blood Vessel Formation in Multiple Sclerosis
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|ClinicalTrials.gov Identifier: NCT00064909|
Recruitment Status : Completed
First Posted : July 15, 2003
Last Update Posted : March 4, 2008
|First Submitted Date||July 14, 2003|
|First Posted Date||July 15, 2003|
|Last Update Posted Date||March 4, 2008|
|Study Start Date||July 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures||Not Provided|
|Original Primary Outcome Measures||Not Provided|
|Current Secondary Outcome Measures||Not Provided|
|Original Secondary Outcome Measures||Not Provided|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title||MR Perfusion Imaging and Hypercapnia (Increased Carbon Dioxide) to Study New Blood Vessel Formation in Multiple Sclerosis|
|Official Title||Using MR Perfusion Imaging and Hypercapnia to Study Angiogenesis in Multiple Sclerosis Patients|
This study will use magnetic resonance imaging (MRI) to examine and compare changes in blood flow and blood volume in the brains of normal volunteers and patients with multiple sclerosis (MS). Patients with MS-an inflammatory disease that attacks the brain and spine-may have new blood vessel formation (called angiogenesis) within the brain that may or may not contribute to the disease or help in repairing the brain. It is not known if these new vessels behave in the same way as the naturally occurring vessels. MRI uses a strong magnetic field and radio waves to generate brain images that provide information on brain chemistry, function, and blood flow. The results of this study may lead to a better understanding of MS.
Healthy normal volunteers and patients with multiple sclerosis 18 years of age and older may be eligible for this study. Normal volunteers must have no history of signs or symptoms of central nervous system disease. Patients with MS will be recruited from the NIH Neuroimmunology MS clinic.
All participants will undergo MRI. For this procedure, the subject lies still on a table that slides into a narrow metal cylinder (the MRI scanner). Scanning varies from 20 minutes to 3 hours, with most scans lasting between 45 and 90 minutes. During the scan, the subject wears earplugs to muffle loud knocking noises caused by electrical switching of the radio frequency circuits. The subject can communicate with the MRI staff at all times during the procedure.
During the scan, the subject wears a mask and breathes in room air or air containing 6% carbon dioxide (CO2). (Room air contains approximately 0.04% CO2, which is about 150 times less than the 6% CO2. Air that is normally breathed out contains about 5% CO2.) Breathing 6% CO2 increases the amount of blood flow in the brain that can be measured using MRI. The total duration of a single 6 percent CO2 inhalation will not exceed 10 minutes.
A catheter (thin plastic tube) is placed in a vein in the subject's arm before he or she enters the scanner. At some point during the scan, a contrast agent called gadolinium DTPA is injected into the vein through the catheter. This agent enables clearer images of the brain.
|Detailed Description||Advances in MR perfusion imaging have provided clinical researchers with the opportunity to quantify regional cerebral blood flow (CBF). Recently, new vessel proliferation and formation (angiogenesis) has been observed in autopsy and biopsy specimens from patients with multiple sclerosis (MS). Newly formed MS lesions, showed strikingly increased numbers of new vessels and similar patterns were observed in and around older lesions, areas of remyelination (new myelin formation on axons, shadow plaques) and normal-appearing brain tissue. The purpose of this study is to compare CBF of MS patients, to age- and gender-matched healthy controls. CBF will be measured while subjects are inhaling room air and the increase in CBF while inhaling a mixture of room air and a known concentration of carbon dioxide (hypercapnia) will be compared. If significant new vessels growth has occurred in the brains of MS patients then this new vessel formation (neovascularization) may be reflected by a change in CBF. Comparing the CBF response to hypercapnia will determine if the newly formed vasculature includes properly functioning blood vessels. Normal cerebral blood vessels are exquisitely sensitive to the carbon dioxide in arterial blood and an increase in carbon dioxide causes CBF to increase through dilatation or relaxation of the muscles surrounding the blood vessels. In the future, changes in the hypercapnia-induced CBF response between MS patients and controls may help to monitor the treatment of the disease.|
|Study Design||Not Provided|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Study Groups/Cohorts||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Original Enrollment||Same as current|
|Study Completion Date||March 2006|
|Primary Completion Date||Not Provided|
INCLUSION CRITERIA (NORMAL VOLUNTEERS)
Any healthy volunteer above the age of 18 who is capable of giving informed consent recruited or self referred through the NIH Volunteer office will be eligible for this study.
All healthy normal volunteers will be required to fill out the questionnaire in Appendix B.
Normal volunteers will be included as long as they have no recorded or documented signs or symptoms of CNS disease, contraindications to an MRI and have a 'normal age-appropriate' MRI of the brain.
Only patients seen in the Neuroimmunology MS clinic with a confirmed diagnosis of Multiple Sclerosis based upon previous history of two clinical neurological attacks separated in time and in spatial location or combination of Clinical and MRI findings of a single enhancing lesion in the brain or spine along with multiple T2 hyperintensities in the juxtacortical, periventricular or infratentorial white matter according to the McDonald criteria will be included in this study.
Relapsing-remitting or secondary progressive MS who have had more than one relapse within 18 months preceding study enrollment will be recruited from the MS 7th floor clinic in the NINDS at the NIH.
MS patients EDSS score between 1.0 - 6.5, inclusive.
Give written informed consent prior to any testing under this protocol, including screening/pre-treatment tests and evaluations that are not considered part of the patient's routine care.
Healthy Controls and MS patients will be excluded if they have contraindications to MR scanning, such as the following:
Healthy controls and MS patients will be excluded from this study if they have the following:
MS patients will also be excluded from study entry if the following exclusion criteria exists at the time of enrollment:
1) Diagnosis of primary progressive MS, defined as gradual progression of disability from the onset without relapses.
|Ages||Child, Adult, Older Adult|
|Accepts Healthy Volunteers||No|
|Contacts||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries||United States|
|Removed Location Countries|
|Other Study ID Numbers||030247
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor||National Institutes of Health Clinical Center (CC)|
|PRS Account||National Institutes of Health Clinical Center (CC)|
|Verification Date||March 2006|