Multiple SclerosisNCT00321568
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 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2006to 19 Apr 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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).
- HEALTHY VOLUNTEERS INCLUSION CRITERIA:
- 1. Age between 18 and 65
- HEALTHY VOLUNTEERS EXCLUSION CRITERIA:
- 1. Same as for patients.
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 and White Matter Damage in Patients With Multiple Sclerosis Using Magnetic Resonance Imaging at 7 Tesla
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.
Read more
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.
...
Read the detailed description
OBJECTIVE: Among the factors contributing to the poor identification of grey and white matter pathology of multiple sclerosis (MS) patients, the low signal-to-noise ratio and consequential poor resolution of magnetic resonance imaging (MRI) obtained at conventional magnetic fields (i.e. 1.5 Tesla) play a significant role. Preliminary results suggest that 7T-MRI has the capability to disclose characteristics of chronic white matter lesions' heterogeneity in MS, not seen at lower field MRI. We now aim to extend those results by investigating whether lesions' heterogeneous appearance pertain not only to chronic lesions, i.e. those studied thus far, but also to newly formed lesions, i.e. those enhancing upon gadolinium injection. The latter can be identified only by imaging at 7T with contrast injection those MS patients known to already have active lesions.
STUDY POPULATION: Up to 145 patients (age range: 18-65, range in the Expanded Disability Status Scale: 0-4.5) with definite MS according to Poser criteria or other diseases of the central nervous system resembling MS from an imaging stand point and up to 120 age/gender-matched healthy volunteers will be enrolled.
DESIGN: Patients previously shown to meet both the clinical and MRI criteria for MS and an equivalent number of gender- and age-matched healthy volunteers will be studied. Initially, both patients and healthy individuals will have conventional 1.5Tesla MRI T1-weighted scans without contrast, whereas patients will also have post-contrast scans. Next, both groups of subjects will be imaged on both the 3 Tesla and 7 Tesla MRIs in a random order. In each 3 Tesla and 7 Tesla MRI study the examination will include the following sequences: 3 dimensional inversion-recovery-prepared fast spoiled gradient recalled images, 3D-fluid-attenuated inversion recovery and double inversion recovery in addition to T1 and T2 conventional weighted images.
A second group of 15 patients with or without clinical relapse who are known to be in an active stage of MS as seen by post-contrast MRI will be imaged. Each patient may undergo a standard 3T MRI within the two weeks before the 7T MRI (if needed, as no information regarding his/her disease status are otherwise available from 3T MRI performed under other NIB protocols). The former will allow ascertaining in advance his/her status of lesions activity, thus providing an adequate number of patients with active lesions imaged at 7T. Each patient may need to repeat his/her scan three times in case of magnetic instability during image acquisition. Additional 3T and 7T MRIs will be performed after 1 and 6 months to follow active lesions evolution over time.
A third group of patients with MS or any other disease of the central nervous system manifesting in magnetic resonance imaging with lesions of the white matter and grey matter which could mimic MS will be included. Each patient will undergo a 3T MRI inclusive of post-contrast sequences as well as a 7T MRI.
OUTCOME MEASURES: The number of cortical lesions as well as white matter and deep grey abnormalities will be computed on images obtained at 1.5, 3 and 7 Tesla MRIs. The study will not aim at conducting a formal comparison of cortical or white matters lesions seen on 3 Tesla and 7 Tesla. Instead, the goal is to provide preliminary information that can be used to design a formal analysis of the sensitivities of the two platforms in studying those abnormalities seen in MS. Active lesions found to be conspicuous upon contrast injection will be compared between T1 and gradient echo images at 7T. Additionally, the evolution of active lesions over time at 7T will be evaluated.
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Magnetic Resonance, MRI, Magnetic Field, MS
- 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 posted4 May 2006 (estimated)
- Study start1 May 2006
- Study completion19 Apr 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
- 60 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00321568
- Sponsor's protocol ID
- 060154
- Other IDs
- 06-N-0154
- Status last verified
- 19 Apr 2011
- First submitted
- 3 May 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
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.
PubMed 14016083Kidd 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.
PubMed 10050891Peterson 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.
PubMed 11558796
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 and White Matter Damage in Patients With Multiple Sclerosis Using Magnetic Resonance Imaging at 7 Tesla
- ClinicalTrials.gov ID
- NCT00321568
- Acronym / sponsor ID
- 060154
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Magnetic Resonance, MRI, Magnetic Field, MS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 1 May 2006
- Study completion
- 19 Apr 2011
- First posted
- 4 May 2006 (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 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.
...
Detailed description
OBJECTIVE: Among the factors contributing to the poor identification of grey and white matter pathology of multiple sclerosis (MS) patients, the low signal-to-noise ratio and consequential poor resolution of magnetic resonance imaging (MRI) obtained at conventional magnetic fields (i.e. 1.5 Tesla) play a significant role. Preliminary results suggest that 7T-MRI has the capability to disclose characteristics of chronic white matter lesions' heterogeneity in MS, not seen at lower field MRI. We now aim to extend those results by investigating whether lesions' heterogeneous appearance pertain not only to chronic lesions, i.e. those studied thus far, but also to newly formed lesions, i.e. those enhancing upon gadolinium injection. The latter can be identified only by imaging at 7T with contrast injection those MS patients known to already have active lesions.
STUDY POPULATION: Up to 145 patients (age range: 18-65, range in the Expanded Disability Status Scale: 0-4.5) with definite MS according to Poser criteria or other diseases of the central nervous system resembling MS from an imaging stand point and up to 120 age/gender-matched healthy volunteers will be enrolled.
DESIGN: Patients previously shown to meet both the clinical and MRI criteria for MS and an equivalent number of gender- and age-matched healthy volunteers will be studied. Initially, both patients and healthy individuals will have conventional 1.5Tesla MRI T1-weighted scans without contrast, whereas patients will also have post-contrast scans. Next, both groups of subjects will be imaged on both the 3 Tesla and 7 Tesla MRIs in a random order. In each 3 Tesla and 7 Tesla MRI study the examination will include the following sequences: 3 dimensional inversion-recovery-prepared fast spoiled gradient recalled images, 3D-fluid-attenuated inversion recovery and double inversion recovery in addition to T1 and T2 conventional weighted images.
A second group of 15 patients with or without clinical relapse who are known to be in an active stage of MS as seen by post-contrast MRI will be imaged. Each patient may undergo a standard 3T MRI within the two weeks before the 7T MRI (if needed, as no information regarding his/her disease status are otherwise available from 3T MRI performed under other NIB protocols). The former will allow ascertaining in advance his/her status of lesions activity, thus providing an adequate number of patients with active lesions imaged at 7T. Each patient may need to repeat his/her scan three times in case of magnetic instability during image acquisition. Additional 3T and 7T MRIs will be performed after 1 and 6 months to follow active lesions evolution over time.
A third group of patients with MS or any other disease of the central nervous system manifesting in magnetic resonance imaging with lesions of the white matter and grey matter which could mimic MS will be included. Each patient will undergo a 3T MRI inclusive of post-contrast sequences as well as a 7T MRI.
OUTCOME MEASURES: The number of cortical lesions as well as white matter and deep grey abnormalities will be computed on images obtained at 1.5, 3 and 7 Tesla MRIs. The study will not aim at conducting a formal comparison of cortical or white matters lesions seen on 3 Tesla and 7 Tesla. Instead, the goal is to provide preliminary information that can be used to design a formal analysis of the sensitivities of the two platforms in studying those abnormalities seen in MS. Active lesions found to be conspicuous upon contrast injection will be compared between T1 and gradient echo images at 7T. Additionally, the evolution of active lesions over time at 7T will be evaluated.
Study design
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
Key exclusion criteria (12 listed)
- 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).
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 14016083BROWNELL 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.
- Background: PubMed 10050891Kidd 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.
- Background: PubMed 11558796Peterson 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.
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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 3 inclusion and 12 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 NCT00321568, 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.