Multiple SclerosisNCT00393588
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 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2006to 29 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 60 years
- All sexes
- No healthy volunteers
- Adult
- PATIENT INCLUSION CRITERIA:
- 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.
PATIENT EXCLUSION CRITERIA:
- 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.
- Any contraindications to having study procedures done.
HEALTHY VOLUNTEER INCLUSION CRITERIA:
- Age between 18 and 60.
- Vital signs are found within the normal range at the time of the screening visit.
HEALTHY VOLUNTEER EXCLUSION CRITERIA:
- Clinically significant medical condition that, in the opinion of the investigator, would compromise the 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.
- Previous eye surgery of any kind.
- Inability to provide informed consent.
- 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 (e.g. dark blue and dark green) whose content in iron 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 subject'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 the subject's eyes.
- A severe auto accident in the past so if it is uncertain whether any metal may still be imbedded in the subject'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.
- Any contraindications to having study procedures done.
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: The Use of Magnetic Resonance Imaging to Investigate Cortical Damage in Patients With Multiple Sclerosis and Correlation With Cognitive Dysfunction
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
Read the detailed description
OBJECTIVE: The study will evaluate cognitive impairment in patients with multiple sclerosis (MS) and correlate the degree of cognitive dysfunction as identified by scores obtained in multiple cognitive tests with measurements of cortical thickness, cortical lesions and white matter disease on magnetic resonance imaging of brains of MS individuals.
STUDY POPULATION: Study population will consist of 49 patients with relapsing remitting or secondary progressive MS with superimposed relapses who have been treated with Interferon beta at fully tolerated dosages for at least six months, and 49 healthy volunteers matched for gender, age and educational level. We expect to screen 65 individuals per arm in order to be able to enroll 49 individuals per arm, thus meeting the requirements of the sample size calculations.
DESIGN: After screening clinical (rating disability by the means of the Expanded Disability Status Scale [EDSS] score), neurophysiological (e.g. evoked potential tests) and imaging examinations, MS patients and healthy subjects will undergo a neuropsychological evaluation using the Minimal Assessment of Cognitive Function in Multiple Sclerosis (MACFIMS) and the Automated Neuropsychological Assessment Metrics (ANAM), and also a 3 Tesla magnetic resonance imaging (MRI). After 25% and after 50% of projected patients have been enrolled, distribution in MACFIMS will be evaluated to ensure that a broad spectrum of cognitive ability is represented. Cortical thickness, cortical lesions and white matter damage metrics (e.g. lesion load, diffusion tensor and magnetization transfer MRI measures) will be computed. In order to exclude the hypothesis that the presence of fatigue, anxiety and depression, normally occurring in MS patients, might interfere with their cognitive performance, thus acting as confounding factors, scales measuring fatigue and mental status will be administered in all subjects. Scores obtained on these scales will be used as covariates in each of the statistical analyses performed in the present study to account for their possible effects.
OUTCOME MEASURES: The first outcome measure will be the MACFIMS and cortical thickness values. Correlation between these two metrics will be initially performed. Secondly, cortical lesions as well as white matter lesions on T1 and T2 weighted images, magnetization transfer ratios and diffusion tensor imaging metrics of lesional and normal appearing brain tissues will be computed and their impact in determining cognitive impairment will be determined. Thirdly, deep gray matter, white matter and total brain volume measures will be computed and correlated with cognitive function measured by the MACFIMS. Similarly, correlations between clinical disability, as measured by the EDSS score and cognitive impairment, as well as between EDSS score and each of the RMI variables explored in the study will be performed. Finally, the level of correlation between MACFIMS and ANAM tests will be investigated.
- Conditions
- Multiple Sclerosis
- Keywords
- Brain, Cognitive Deficits, Cognitive Testing, MRI, Multiple Sclerosis, MS, Healthy Volunteer, HV
- Medical subject headings
- Multiple Sclerosis, Cognition Disorders
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2006 (estimated)
- Study start26 Oct 2006
- Study completion29 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
- 50 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00393588
- Sponsor's protocol ID
- 070014
- Other IDs
- 07-N-0014
- Status last verified
- 29 Sep 2011
- First submitted
- 27 Oct 2006
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
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.
PubMed 11006371Pugliatti 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.
PubMed 16834700Sospedra M, Martin R. Immunology of multiple sclerosis. Annu Rev Immunol. 2005;23:683-747. doi: 10.1146/annurev.immunol.23.021704.115707.
PubMed 15771584
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
- The Use of Magnetic Resonance Imaging to Investigate Cortical Damage in Patients With Multiple Sclerosis and Correlation With Cognitive Dysfunction
- ClinicalTrials.gov ID
- NCT00393588
- Acronym / sponsor ID
- 070014
- Conditions
- Multiple Sclerosis
- Keywords
- Brain, Cognitive Deficits, Cognitive Testing, MRI, Multiple Sclerosis, MS, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 26 Oct 2006
- Study completion
- 29 Sep 2011
- First posted
- 30 Oct 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 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
Detailed description
OBJECTIVE: The study will evaluate cognitive impairment in patients with multiple sclerosis (MS) and correlate the degree of cognitive dysfunction as identified by scores obtained in multiple cognitive tests with measurements of cortical thickness, cortical lesions and white matter disease on magnetic resonance imaging of brains of MS individuals.
STUDY POPULATION: Study population will consist of 49 patients with relapsing remitting or secondary progressive MS with superimposed relapses who have been treated with Interferon beta at fully tolerated dosages for at least six months, and 49 healthy volunteers matched for gender, age and educational level. We expect to screen 65 individuals per arm in order to be able to enroll 49 individuals per arm, thus meeting the requirements of the sample size calculations.
DESIGN: After screening clinical (rating disability by the means of the Expanded Disability Status Scale [EDSS] score), neurophysiological (e.g. evoked potential tests) and imaging examinations, MS patients and healthy subjects will undergo a neuropsychological evaluation using the Minimal Assessment of Cognitive Function in Multiple Sclerosis (MACFIMS) and the Automated Neuropsychological Assessment Metrics (ANAM), and also a 3 Tesla magnetic resonance imaging (MRI). After 25% and after 50% of projected patients have been enrolled, distribution in MACFIMS will be evaluated to ensure that a broad spectrum of cognitive ability is represented. Cortical thickness, cortical lesions and white matter damage metrics (e.g. lesion load, diffusion tensor and magnetization transfer MRI measures) will be computed. In order to exclude the hypothesis that the presence of fatigue, anxiety and depression, normally occurring in MS patients, might interfere with their cognitive performance, thus acting as confounding factors, scales measuring fatigue and mental status will be administered in all subjects. Scores obtained on these scales will be used as covariates in each of the statistical analyses performed in the present study to account for their possible effects.
OUTCOME MEASURES: The first outcome measure will be the MACFIMS and cortical thickness values. Correlation between these two metrics will be initially performed. Secondly, cortical lesions as well as white matter lesions on T1 and T2 weighted images, magnetization transfer ratios and diffusion tensor imaging metrics of lesional and normal appearing brain tissues will be computed and their impact in determining cognitive impairment will be determined. Thirdly, deep gray matter, white matter and total brain volume measures will be computed and correlated with cognitive function measured by the MACFIMS. Similarly, correlations between clinical disability, as measured by the EDSS score and cognitive impairment, as well as between EDSS score and each of the RMI variables explored in the study will be performed. Finally, the level of correlation between MACFIMS and ANAM tests will be investigated.
Study design
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
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 11006371Noseworthy 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.
- Background: PubMed 16834700Pugliatti 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.
- Background: PubMed 15771584Sospedra M, Martin R. Immunology of multiple sclerosis. Annu Rev Immunol. 2005;23:683-747. doi: 10.1146/annurev.immunol.23.021704.115707.
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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?
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 NCT00393588, 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.