Neurologic DisordersNCT02504840
Natural History of Multiple Sclerosis and Its Mimickers
An observational study of Neurologic Disorders and Healthy Volunteers, run by National Institute of Neurological Disorders and Stroke (NINDS) at 1 site in United States.
Trial summary
Background: Magnetic resonance imaging (MRI) has been used for decades to help diagnose and monitor neurological disorders like multiple sclerosis (MS). Researchers want to improve how MRI pictures are taken. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurologic Disorders, Healthy Volunteers, Multiple Sclerosis
- How many people
- 104 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Jul 2015to 5 Mar 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Up to 1300 participants will be enrolled onto this open-ended thematic protocol. The following study populations will be included:- Participants with definite, probable, or possible MS. These participants either carry a diagnosis of MS, or else their referring clinicians are considering the diagnosis.-Participants with diseases that share imaging features with MS. These participants report clinical symptoms or prior MRI findings that could, in the best judgment of the investigators, be due to inflammatory demyelination of the central nervous system.- Healthy volunteers.-Withdrawals and dropouts will not be replaced.
Who may be able to join
- <TAB>
- One or more of the following:
- Diagnosis of MS, clinically isolated syndrome, or radiologically isolated syndrome.
- Presentation with clinical or neuroimaging findings that, in the best judgment of the investigators, are possibly consistent with central nervous system inflammatory demyelination.
- Healthy volunteer.
- Age greater than or equal to18.
- Able to participate in study procedures and provide high-quality clinical research data, in the best judgment of the investigators.
- Interest of the study investigators in performing one or more procedures under one or more of the substudies.
Who cannot join
- <TAB>
- Unwilling to allow sharing and/or use in future studies of coded samples and data that are collected for this study.
- Inability to provide informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Thematic Studies of Multiple Sclerosis and Related Diseases
Background:
- Magnetic resonance imaging (MRI) has been used for decades to help diagnose and monitor neurological disorders like multiple sclerosis (MS). Researchers want to improve how MRI pictures are taken. They also want to learn more about using newer MRIs with stronger magnets to get better pictures than standard MRIs provide.
Read more
Objectives:
- To collect data that will help researchers better understand MS and related diseases.
Eligibility:
- Adults 18 and older with MS or MRI findings that appear similar to MS, or with other neurological diseases that may look or act like MS.
- Healthy adult volunteers.
Design:
- Participants will be screened with a review of their medical records.
- Participants will have a baseline visit. It will include a physical exam, medical history, and neurological exam. They may have blood tests.
- The study will last indefinitely.
- Participants may have MRIs. Some MRIs may include a contrast dye. For this, a needle will be used to guide a thin plastic tube into an arm vein.
- Participants may have up to 2 lumbar punctures per year. Skin will be numbed and a needle inserted between back bones will remove fluid.
- Participants may give saliva samples and have an eye exam.
- Participants may have evoked potential tests. These measure how the nervous system responds to different types of stimulation. Participants may sit in front of a TV and watch pictures on the screen. Or they may wear earphones that make a clicking noise or static. Or they may get a small electrical shock that may tingle and cause a hand or foot twitch.
- Participants may have tests of strength, spasticity, sensations, balance, and/or walking.
Read the detailed description
Objectives.
The goals of this protocol are to study the pathophysiology of multiple sclerosis (MS), primarily through small studies that utilize magnetic resonance imaging (MRI), and to correlate the results with clinical and biological measures. The protocol includes only techniques with minimal risk (standard and quantitative clinical evaluation, MRI, blood draws, saliva testing, urine and stool collection, visual evoked potentials, ophthalmologic evaluation) or more-than-minimal risk (injection of approved gadolinium-based contrast agents, lumbar punctures) that are appropriate and common in this study population. Under this protocol, we will conduct:
- Pilot substudies. These studies are exploratory and hypothesis generating. Once sufficient data are collected to justify a hypothesis-driven study and a formal power analysis, further work will continue under either a dedicated protocol or, if appropriate, a hypothesis-testing substudy. There are no enrollment limitations for pilot substudies.
- Hypothesis-testing substudy. These studies have a specific hypothesis that can be tested with at most 6 participants per arm. If additional participants are required, a memo will be sent to the Protocol Review Committee (PIRC) and its statistical reviewer to request review of a hypothesis-testing substudy for possible additional enrollment.The memo will also be forwarded to the IRB.
- Individual patient substudies. These studies seek to increase knowledge of a disease process or to assist in the diagnosis of an individual patient.
- Technique development substudies. These studies will lay the groundwork for new experimental paradigms, using the methods approved under this protocol, which can be further tested in the substudies listed above.
- Training of investigators. These studies will be done to train new investigators in techniques relevant to the studies under this protocol.
Study Population
Three groups of study participants will be enrolled:
- MS patients. Participants with definite, probable, or possible MS.
- Patient controls. Participants with diseases that share features with MS.
- Healthy volunteers.
Design
We will design small substudies as ideas arise in the course of our work that are pertinent to the theme of the pathophysiology of MS (or of diseases that share features with MS). If a hypothesis testing sub-study leads to results of interest and if a larger population is necessary to reach statistical significance, a separate protocol will be submitted with a priori hypotheses, specific study design and power analysis adapted from the pilot or exploratory substudies performed in the present protocol.
Outcome Measures
These will include MRI, clinical, and biological outcome measures consistent with the objectives of the study and its investigators. Imaging measures will focus on features related to the central nervous system (CNS), particularly focal lesions. Clinical measures will include standard and established MS disability scales as well as quantitative measures related to function. Biological measures will include genotype, gene expression, proteomics, virological studies, and immunological profiling.
- Conditions
- Neurologic Disorders, Healthy Volunteers, Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Clinically Isolated Syndrome, CNS Inflammatory Demyelination, Radiologically Isolated Syndrome, Natural History
- Medical subject headings
- Nervous System Diseases, Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| healthy volunteers | healthy volunteers | |
| patient controls | Participants with diseases that share features with MS. | |
| patients with suspected or confirmed multiple sclerosis | Participants with definite, probable, or possible MS. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association between clinical status and research data
Imaging measures will focus on features related to the central nervous system (CNS), particularly focal lesions. Clinical measures will include standard and established MS disability scales as well as quantitative measures related to function. Biological measures will include genotype, gene expression, proteomics, virological studies, and immunological profiling.
Measured: over time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2015 (estimated)
- Study start23 Jul 2015
- Primary completion5 Mar 2020
- Study completion5 Mar 2020
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 Neurologic DisordersStudies 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
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Daniel S Reich, M.D., Principal investigator, National Institute of Neurological Disorders and Stroke (NINDS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02504840
- Sponsor's protocol ID
- 150158
- Other IDs
- 15-N-0158
- Status last verified
- Oct 2022
- First submitted
- 21 Jul 2015
- Last updated
- 14 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gaitan MI, Shea CD, Evangelou IE, Stone RD, Fenton KM, Bielekova B, Massacesi L, Reich DS. Evolution of the blood-brain barrier in newly forming multiple sclerosis lesions. Ann Neurol. 2011 Jul;70(1):22-9. doi: 10.1002/ana.22472. Epub 2011 Jun 27.
PubMed 21710622Jones BC, Nair G, Shea CD, Crainiceanu CM, Cortese IC, Reich DS. Quantification of multiple-sclerosis-related brain atrophy in two heterogeneous MRI datasets using mixed-effects modeling. Neuroimage Clin. 2013 Aug 13;3:171-9. doi: 10.1016/j.nicl.2013.08.001. eCollection 2013.
PubMed 24179861McFarland HF, Frank JA, Albert PS, Smith ME, Martin R, Harris JO, Patronas N, Maloni H, McFarlin DE. Using gadolinium-enhanced magnetic resonance imaging lesions to monitor disease activity in multiple sclerosis. Ann Neurol. 1992 Dec;32(6):758-66. doi: 10.1002/ana.410320609.
PubMed 1471866
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Thematic Studies of Multiple Sclerosis and Related Diseases
- ClinicalTrials.gov ID
- NCT02504840
- Acronym / sponsor ID
- 150158
- Conditions
- Neurologic Disorders, Healthy Volunteers, Multiple Sclerosis
- Keywords
- Multiple Sclerosis, Clinically Isolated Syndrome, CNS Inflammatory Demyelination, Radiologically Isolated Syndrome, Natural History
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 104 participants (actual)
- Lead sponsor
- National Institute of Neurological Disorders and Stroke (NINDS)US National Institutes of Health
- Study start
- 23 Jul 2015 (actual)
- Primary completion
- 5 Mar 2020 (actual)
- Study completion
- 5 Mar 2020 (actual)
- First posted
- 22 Jul 2015 (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.
Background:
- Magnetic resonance imaging (MRI) has been used for decades to help diagnose and monitor neurological disorders like multiple sclerosis (MS). Researchers want to improve how MRI pictures are taken. They also want to learn more about using newer MRIs with stronger magnets to get better pictures than standard MRIs provide.
Objectives:
- To collect data that will help researchers better understand MS and related diseases.
Eligibility:
- Adults 18 and older with MS or MRI findings that appear similar to MS, or with other neurological diseases that may look or act like MS.
- Healthy adult volunteers.
Design:
- Participants will be screened with a review of their medical records.
- Participants will have a baseline visit. It will include a physical exam, medical history, and neurological exam. They may have blood tests.
- The study will last indefinitely.
- Participants may have MRIs. Some MRIs may include a contrast dye. For this, a needle will be used to guide a thin plastic tube into an arm vein.
- Participants may have up to 2 lumbar punctures per year. Skin will be numbed and a needle inserted between back bones will remove fluid.
- Participants may give saliva samples and have an eye exam.
- Participants may have evoked potential tests. These measure how the nervous system responds to different types of stimulation. Participants may sit in front of a TV and watch pictures on the screen. Or they may wear earphones that make a clicking noise or static. Or they may get a small electrical shock that may tingle and cause a hand or foot twitch.
- Participants may have tests of strength, spasticity, sensations, balance, and/or walking.
Detailed description
Objectives.
The goals of this protocol are to study the pathophysiology of multiple sclerosis (MS), primarily through small studies that utilize magnetic resonance imaging (MRI), and to correlate the results with clinical and biological measures. The protocol includes only techniques with minimal risk (standard and quantitative clinical evaluation, MRI, blood draws, saliva testing, urine and stool collection, visual evoked potentials, ophthalmologic evaluation) or more-than-minimal risk (injection of approved gadolinium-based contrast agents, lumbar punctures) that are appropriate and common in this study population. Under this protocol, we will conduct:
- Pilot substudies. These studies are exploratory and hypothesis generating. Once sufficient data are collected to justify a hypothesis-driven study and a formal power analysis, further work will continue under either a dedicated protocol or, if appropriate, a hypothesis-testing substudy. There are no enrollment limitations for pilot substudies.
- Hypothesis-testing substudy. These studies have a specific hypothesis that can be tested with at most 6 participants per arm. If additional participants are required, a memo will be sent to the Protocol Review Committee (PIRC) and its statistical reviewer to request review of a hypothesis-testing substudy for possible additional enrollment.The memo will also be forwarded to the IRB.
- Individual patient substudies. These studies seek to increase knowledge of a disease process or to assist in the diagnosis of an individual patient.
- Technique development substudies. These studies will lay the groundwork for new experimental paradigms, using the methods approved under this protocol, which can be further tested in the substudies listed above.
- Training of investigators. These studies will be done to train new investigators in techniques relevant to the studies under this protocol.
Study Population
Three groups of study participants will be enrolled:
- MS patients. Participants with definite, probable, or possible MS.
- Patient controls. Participants with diseases that share features with MS.
- Healthy volunteers.
Design
We will design small substudies as ideas arise in the course of our work that are pertinent to the theme of the pathophysiology of MS (or of diseases that share features with MS). If a hypothesis testing sub-study leads to results of interest and if a larger population is necessary to reach statistical significance, a separate protocol will be submitted with a priori hypotheses, specific study design and power analysis adapted from the pilot or exploratory substudies performed in the present protocol.
Outcome Measures
These will include MRI, clinical, and biological outcome measures consistent with the objectives of the study and its investigators. Imaging measures will focus on features related to the central nervous system (CNS), particularly focal lesions. Clinical measures will include standard and established MS disability scales as well as quantitative measures related to function. Biological measures will include genotype, gene expression, proteomics, virological studies, and immunological profiling.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| healthy volunteers | – | –healthy volunteers |
| patient controls | – | –Participants with diseases that share features with MS. |
| patients with suspected or confirmed multiple sclerosis | – | –Participants with definite, probable, or possible MS. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Up to 1300 participants will be enrolled onto this open-ended thematic protocol. The following study populations will be included:- Participants with definite, probable, or possible MS. These participants either carry a diagnosis of MS, or else their referring clinicians are considering the diagnosis.-Participants with diseases that share imaging features with MS. These participants report clinical symptoms or prior MRI findings that could, in the best judgment of the investigators, be due to inflammatory demyelination of the central nervous system.- Healthy volunteers.-Withdrawals and dropouts will not be replaced.
Key inclusion criteria (8 listed)
- <TAB>
- One or more of the following:
- Age greater than or equal to18.
- Able to participate in study procedures and provide high-quality clinical research data, in the best judgment of the investigators.
- Interest of the study investigators in performing one or more procedures under one or more of the substudies.
Key exclusion criteria (3 listed)
- <TAB>
- Unwilling to allow sharing and/or use in future studies of coded samples and data that are collected for this study.
- Inability to provide informed consent.
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
Association between clinical status and research data
Time frame: over time
Imaging measures will focus on features related to the central nervous system (CNS), particularly focal lesions. Clinical measures will include standard and established MS disability scales as well as quantitative measures related to function. Biological measures will include genotype, gene expression, proteomics, virological studies, and immunological profiling.
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 14 Oct 2022.
- Background: PubMed 21710622Gaitan MI, Shea CD, Evangelou IE, Stone RD, Fenton KM, Bielekova B, Massacesi L, Reich DS. Evolution of the blood-brain barrier in newly forming multiple sclerosis lesions. Ann Neurol. 2011 Jul;70(1):22-9. doi: 10.1002/ana.22472. Epub 2011 Jun 27.
- Background: PubMed 24179861Jones BC, Nair G, Shea CD, Crainiceanu CM, Cortese IC, Reich DS. Quantification of multiple-sclerosis-related brain atrophy in two heterogeneous MRI datasets using mixed-effects modeling. Neuroimage Clin. 2013 Aug 13;3:171-9. doi: 10.1016/j.nicl.2013.08.001. eCollection 2013.
- Background: PubMed 1471866McFarland HF, Frank JA, Albert PS, Smith ME, Martin R, Harris JO, Patronas N, Maloni H, McFarlin DE. Using gadolinium-enhanced magnetic resonance imaging lesions to monitor disease activity in multiple sclerosis. Ann Neurol. 1992 Dec;32(6):758-66. doi: 10.1002/ana.410320609.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
Daniel S Reich, M.D. principal investigator
National Institute of Neurological Disorders and Stroke (NINDS)
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 Neurologic Disorders and Healthy Volunteers, 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 3 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 14 Oct 2022. 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.
What does the primary outcome measure?
Association between clinical status and research data (time frame: over time). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02504840, 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 14 Oct 2022.