Multiple SclerosisNCT00099307
Magnetic Resonance Imaging to Detect Brain Damage in Patients With Multiple Sclerosis
An observational study of Multiple Sclerosis, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
This study will determine whether magnetic resonance imaging (MRI) can detect damage to certain parts of the brain and analyze the thickness of the brain's outer surface in patients with multiple sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2004to 28 Sep 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of clinically isolated syndrome or MS.
- Age between 18 and 55.
- EDSS between 0 and 6.5.
- Age greater than 18 years.
- Age greater than 18 years.
- Pure motor hemiparesis secondary to a first and single acute ischemic infarct localized in the white matter of the pyramidal tract (confirmation and location stroke by MRI).
- No other major diseases of the central nervous system or neurological signs.
- No other visible MRI lesions of the corticospinal tract on T2-weighted images (e.g., patients with white matter lesions on tracts not connected with the pyramidal tract and clinically silent will not be excluded).
Who cannot join
- Presence of clinical relapse at the time of the enrollment or within the previous 3 months.
- Concomitant systemic disorder or central nervous system diseases of any kind or other related risk factors.
- Previous history of alcohol and substances abuse.
- Medical contraindications for MRI.
- Psychological contraindications for MRI.
- Pregnancy.
Show all 20Show fewer
- Unable to provide informed consent.
- Systemic disorder or central nervous system diseases of any kind or other related risk factors.
- Previous history of alcohol and substances abuse.
- Medical contraindications for MRI.
- Psychological contraindications for MRI.
- Pregnancy.
- Unable to provide informed consent.
- Stroke onset less than 3 months prior to the study enrollment.
- Previous history of alcohol and substances abuse.
- Medical contraindications for MRI.
- Contraindications for MRI.
- Critical stenosis of either carotids or vertebrobasilar artery as demonstrated by a Transcranial Doppler.
- Pregnancy.
- Unable to provide informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: An Exploratory Study on Detection of Cortical Damage in Patients With Multiple Sclerosis Using Magnetic Resonance Imaging
This study will determine whether magnetic resonance imaging (MRI) can detect damage to certain parts of the brain and analyze the thickness of the brain's outer surface in patients with multiple sclerosis. MRI is a diagnostic test that uses a strong magnetic field and radio waves to obtain images of body organs and tissues. It can sometimes permit diagnosis even before symptoms develop.
MS is a disease of white matter, the fatty covering around the nerves in the brain and spinal cord. The nerves themselves are called gray matter. Damage to white matter impairs nerve function, leading to a variety of symptoms, such as weakness, vision problems, difficulty walking, paralysis, and others. MRI can detect some changes in white matter, but changes that may also appear in gray matter may be more difficult to find. This study will use new MRI techniques to try to identify gray matter damage in patients with MS.
Read more
Healthy volunteers and people with MS or clinically isolated syndrome (an early stage of MS in which the patient has had just one of the problems MS can cause) who are between 18 and 55 years of age may be eligible for this study. Candidates are screened with a medical history and neurological examination, and blood and urine tests.
Within one month of the screening evaluation, participants undergo MRI scanning on a standard 1.5 Tesla machine to confirm their health status. (The power of the MRI scanner is measured in Tesla; the higher the Tesla, the better the visualization.) For this procedure, the subject lies on a table that moves into the scanner (a narrow cylinder with a magnetic field), and wears earplugs to muffle loud knocking and thumping sounds that occur during the scanning process. During the procedure, a contrast agent called Gadolinium is injected into the blood stream to brighten the images. The test lasts about 2 hours, during which time the subject must lie still for up to a few minutes at a time.
Within a month after the first MRI, participants repeat the test for a second time. The procedure is identical to the first scan, except a 3.0 Tesla machine is used.
Read the detailed description
OBJECTIVE: Detection of cortical lesions in patients with multiple sclerosis (MS) using magnetic resonance imaging (MRI) is challenging. Their identification might provide more insight in explaining the level of disability in patients with MS.
Primary aim of the present study is identifying cortical lesions in patients with MS using MRI. As a secondary aim, correlation between cortical lesions presence and clinical disability score (i.e. Expanded Disability Status Score or EDSS scale) will be analyzed. Tertiary aims will be provided by the relationships between the presence of cortical lesions and reduction in cortical thickness and extent of remote white matter disease pathology. Additionally, the role of white matter lesions in causing remote pathology will be studied. To better characterize this damage, patients with previous stroke, presenting with a single lesion on the pyramidal tract will be enrolled and diffusion-derived indices of white matter remote tracts will be computed.
STUDY POPULATION: Fifty patients with definite MS or with a single attack and an MRI suggestive of MS (i.e., clinically isolated syndrome) according to McDonald criteria, and 55 healthy volunteers will be enrolled. Fifteen patients with previous ischemic stroke and 15 age- and gender-matched healthy volunteers will also be enrolled.
DESIGN: After a clinical evaluation and an MRI at 1.5 Tesla, each individual will be imaged once at 3.0 Tesla scan. Clinical MRI before and within 15 minutes after contrast injection will be obtained in each patient at both 1.5 and 3 Tesla scans. In addition, 3 spoiled gradient-echo sequence, diffusion tensor images and double inversion recovery sequences will be acquired on the 3 Tesla MRI. Some healthy volunteers (up to 15) and patients (up to 15) will be required to be imaged twice on the 3T magnet as to optimize the sequences of this study. Additionally, 20 patients in whom cortical lesions will be identified using the above-mentioned techniques and 20 healthy volunteers will undergo brain perfusion MRIs. This may represent the third 3T MRI for the former in some instances.
OUTCOME MEASURES: In MS patients, the number of cortical lesions will be computed. The EDSS score will serve for investigating the relationship between cortical lesions and clinical disability. Effect of cortical or white matter lesions in causing remote degeneration will be studied using diffusion tensor and magnetization transfer imaging in patients with both stroke and MS.
- Conditions
- Multiple Sclerosis
- Keywords
- White Matter, Grey Matter, Brain, Disability, Lesions, Multiple Sclerosis, MS, Healthy Volunteer, HV
- Medical subject headings
- Multiple Sclerosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2004 (estimated)
- Study start8 Dec 2004
- Study completion28 Sep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by National Institute of Neurological Disorders and Stroke (NINDS)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00099307
- Sponsor's protocol ID
- 050039
- Other IDs
- 05-N-0039
- Status last verified
- 28 Sep 2011
- First submitted
- 10 Dec 2004
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
McFarland HF. The emerging role of MRI in multiple sclerosis and the new diagnostic criteria. Mult Scler. 2002 Feb;8(1):71-2. doi: 10.1177/135245850200800114. No abstract available.
PubMed 11936491Li DK, Zhao G, Paty DW. T2 hyperintensities: findings and significance. Neuroimaging Clin N Am. 2000 Nov;10(4):717-38 ,ix.
PubMed 11359721Harris JO, Frank JA, Patronas N, McFarlin DE, McFarland HF. Serial gadolinium-enhanced magnetic resonance imaging scans in patients with early, relapsing-remitting multiple sclerosis: implications for clinical trials and natural history. Ann Neurol. 1991 May;29(5):548-55. doi: 10.1002/ana.410290515.
PubMed 1859184
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Study on Detection of Cortical Damage in Patients With Multiple Sclerosis Using Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT00099307
- Acronym / sponsor ID
- 050039
- Conditions
- Multiple Sclerosis
- Keywords
- White Matter, Grey Matter, Brain, Disability, Lesions, Multiple Sclerosis, MS, Healthy Volunteer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 8 Dec 2004
- Study completion
- 28 Sep 2011
- First posted
- 10 Dec 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine whether magnetic resonance imaging (MRI) can detect damage to certain parts of the brain and analyze the thickness of the brain's outer surface in patients with multiple sclerosis. MRI is a diagnostic test that uses a strong magnetic field and radio waves to obtain images of body organs and tissues. It can sometimes permit diagnosis even before symptoms develop.
MS is a disease of white matter, the fatty covering around the nerves in the brain and spinal cord. The nerves themselves are called gray matter. Damage to white matter impairs nerve function, leading to a variety of symptoms, such as weakness, vision problems, difficulty walking, paralysis, and others. MRI can detect some changes in white matter, but changes that may also appear in gray matter may be more difficult to find. This study will use new MRI techniques to try to identify gray matter damage in patients with MS.
Healthy volunteers and people with MS or clinically isolated syndrome (an early stage of MS in which the patient has had just one of the problems MS can cause) who are between 18 and 55 years of age may be eligible for this study. Candidates are screened with a medical history and neurological examination, and blood and urine tests.
Within one month of the screening evaluation, participants undergo MRI scanning on a standard 1.5 Tesla machine to confirm their health status. (The power of the MRI scanner is measured in Tesla; the higher the Tesla, the better the visualization.) For this procedure, the subject lies on a table that moves into the scanner (a narrow cylinder with a magnetic field), and wears earplugs to muffle loud knocking and thumping sounds that occur during the scanning process. During the procedure, a contrast agent called Gadolinium is injected into the blood stream to brighten the images. The test lasts about 2 hours, during which time the subject must lie still for up to a few minutes at a time.
Within a month after the first MRI, participants repeat the test for a second time. The procedure is identical to the first scan, except a 3.0 Tesla machine is used.
Detailed description
OBJECTIVE: Detection of cortical lesions in patients with multiple sclerosis (MS) using magnetic resonance imaging (MRI) is challenging. Their identification might provide more insight in explaining the level of disability in patients with MS.
Primary aim of the present study is identifying cortical lesions in patients with MS using MRI. As a secondary aim, correlation between cortical lesions presence and clinical disability score (i.e. Expanded Disability Status Score or EDSS scale) will be analyzed. Tertiary aims will be provided by the relationships between the presence of cortical lesions and reduction in cortical thickness and extent of remote white matter disease pathology. Additionally, the role of white matter lesions in causing remote pathology will be studied. To better characterize this damage, patients with previous stroke, presenting with a single lesion on the pyramidal tract will be enrolled and diffusion-derived indices of white matter remote tracts will be computed.
STUDY POPULATION: Fifty patients with definite MS or with a single attack and an MRI suggestive of MS (i.e., clinically isolated syndrome) according to McDonald criteria, and 55 healthy volunteers will be enrolled. Fifteen patients with previous ischemic stroke and 15 age- and gender-matched healthy volunteers will also be enrolled.
DESIGN: After a clinical evaluation and an MRI at 1.5 Tesla, each individual will be imaged once at 3.0 Tesla scan. Clinical MRI before and within 15 minutes after contrast injection will be obtained in each patient at both 1.5 and 3 Tesla scans. In addition, 3 spoiled gradient-echo sequence, diffusion tensor images and double inversion recovery sequences will be acquired on the 3 Tesla MRI. Some healthy volunteers (up to 15) and patients (up to 15) will be required to be imaged twice on the 3T magnet as to optimize the sequences of this study. Additionally, 20 patients in whom cortical lesions will be identified using the above-mentioned techniques and 20 healthy volunteers will undergo brain perfusion MRIs. This may represent the third 3T MRI for the former in some instances.
OUTCOME MEASURES: In MS patients, the number of cortical lesions will be computed. The EDSS score will serve for investigating the relationship between cortical lesions and clinical disability. Effect of cortical or white matter lesions in causing remote degeneration will be studied using diffusion tensor and magnetization transfer imaging in patients with both stroke and MS.
Study design
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosis of clinically isolated syndrome or MS.
- Age between 18 and 55.
- EDSS between 0 and 6.5.
- Age greater than 18 years.
- Age greater than 18 years.
Key exclusion criteria (20 listed)
- Presence of clinical relapse at the time of the enrollment or within the previous 3 months.
- Concomitant systemic disorder or central nervous system diseases of any kind or other related risk factors.
- Previous history of alcohol and substances abuse.
- Medical contraindications for MRI.
- Psychological contraindications for MRI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 11936491McFarland HF. The emerging role of MRI in multiple sclerosis and the new diagnostic criteria. Mult Scler. 2002 Feb;8(1):71-2. doi: 10.1177/135245850200800114. No abstract available.
- Background: PubMed 11359721Li DK, Zhao G, Paty DW. T2 hyperintensities: findings and significance. Neuroimaging Clin N Am. 2000 Nov;10(4):717-38 ,ix.
- Background: PubMed 1859184Harris JO, Frank JA, Patronas N, McFarlin DE, McFarland HF. Serial gadolinium-enhanced magnetic resonance imaging scans in patients with early, relapsing-remitting multiple sclerosis: implications for clinical trials and natural history. Ann Neurol. 1991 May;29(5):548-55. doi: 10.1002/ana.410290515.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00099307, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jul 2017.