Multiple SclerosisNCT03723356
Linking Cognitive Functioning to Multimodal Imaging in Multiple Sclerosis (MS)
An observational study of Multiple Sclerosis and Cognition Disorders, run by NYU Langone Health at 1 site in United States.
Trial summary
Multiple sclerosis (MS) is the most common progressive neurologic disorder to occur in adults of working-age. Despite longstanding recognition of cognitive impairment as a symptom of MS, two obstacles in measurement have limited understanding its biological basis, and therefore identifying targeted options for… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis, Cognition Disorders
- What is being tested?
- Siemens Biograph mMR (molecular MR), fMRI and Diffusion Spectrum Imaging (DSI)
- Type of treatment
- Injection or infusion
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2018to 9 Jan 2021
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: 20 MS participants and 10 healthy controls. However, the data analysis is planned for 15 MS participants and 10 healthy control participants. It is expected that 15 MS subjects and 10 healthy controls will complete 12 months.
Who may be able to join
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
- Male and Female subjects between 18 and 45 years
- WRAT-4 Reading [127] standard score > 85
- Able to undergo neuroimaging data collection procedures. For MS Participants
- Definite diagnosis of RRMS [128]
- EDSS of 0 to 6.0
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- Adequate vision as as reported by the participant (with correction if applicable)
- Clinically prescribed Tecfidera, Tysabri or Ocrevus therapy by treating neurologist, with first dose being within 3 months + 14 days from baseline visit
- At baseline visit, concurrent medications to be kept constant over three months prior to data collection visits
- No relapse or steroids in previous month
Who cannot join
- Unable or unwilling to provide informed consent.
- Beck Depression Inventory-Fast Screen (BDI-FS) [129, 130] score of 4 or more
- Current alcohol or other substance use disorder
- Primary psychiatric disorder that would adversely influence ability to participate
- Other neurological condition associated with cognitive impairment (e.g., epilepsy, brain injury)
- Other serious uncontrolled medical condition (e.g., cancer or acute myocardial infarction)
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- Learned English language after 12 years of age
- For low absolute low lymphocyte count (ALC), USPI guidance will be utilized.
- For MS participants:
- Lemtrada, Cladribine, Mitoxantrone
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: Linking Cognitive Functioning to Multimodal Imaging in Multiple Sclerosis
Multiple sclerosis (MS) is the most common progressive neurologic disorder to occur in adults of working-age. Despite longstanding recognition of cognitive impairment as a symptom of MS, two obstacles in measurement have limited understanding its biological basis, and therefore identifying targeted options for management. First is the absence of a sensitive and precise measure of cognitive impairment. Second is the absence of an index of disease status linked to brain pathophysiology and cognitive performance. This project overcomes both obstacles to link cognitive impairment to MS disease biomarkers. The absence of a sensitive and precise measure of cognitive impairment, along with the absence of an index of disease status linked to brain pathophysiology and cognitive performance, limits the understanding of the biological basis for multiple sclerosis (MS). This project overcomes both obstacles to link cognitive function to MS disease biomarkers, and provides preliminary evaluation of a disease modifying therapy (Tecfidera) for preserving cognitive function.
- Conditions
- Multiple Sclerosis, Cognition Disorders
- Being tested
- Siemens Biograph mMR (molecular MR), fMRI, Diffusion Spectrum Imaging (DSI)
- Medical subject headings
- Multiple Sclerosis, Cognition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Siemens Biograph mMR (molecular MR)Diagnostic test
5mCi of the radiotracer FDG administered intravenously as a bolus over 30s. After injection, emission data will be collected for 60 min,
fMRIDiagnostic test
High-resolution T1-weighted structural image will be acquired using an MP2RAGE sequence. Subject will beasked to look at the cross hair on a screen andnot fixate on any one thought.
Diffusion Spectrum Imaging (DSI)Diagnostic test
DSI allows for more accurate characterization of diffusion,overcomes traditional dMRI artifacts, and is capable of more precise and detailedcharacterization of white matter fibers
| Study group | Role | What they receive |
|---|---|---|
| MS Patients | Definite diagnosis of RRMS Receives: Diagnostic Test: Siemens Biograph mMR (molecular MR); Diagnostic Test: fMRI; Diagnostic Test: Diffusion Spectrum Imaging (DSI) | |
| Healthy Controls | gender aged match healthy Receives: Diagnostic Test: Siemens Biograph mMR (molecular MR); Diagnostic Test: fMRI; Diagnostic Test: Diffusion Spectrum Imaging (DSI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
intraindividual variation (ie IIV) in reaction times across the trials of the Attention Network Test (ANT)
Attention Network Test (ANT) is a cognitive reaction time test administered on the computer, where the subject indicates when they see a target on a screen.
Measured: Baseline
intraindividual variation (ie IIV) in reaction times across the trials of the Attention Network Test (ANT)
Attention Network Test (ANT) is a cognitive reaction time test administered on the computer, where the subject indicates when they see a target on a screen.
Measured: 3 Months
intraindividual variation (ie IIV) in reaction times across the trials of the Attention Network Test (ANT)
Attention Network Test (ANT) is a cognitive reaction time test administered on the computer, where the subject indicates when they see a target on a screen.
Measured: 6 Months
intraindividual variation (ie IIV) in reaction times across the trials of the Attention Network Test (ANT)
Attention Network Test (ANT) is a cognitive reaction time test administered on the computer, where the subject indicates when they see a target on a screen.
Measured: 9 Months
intraindividual variation (ie IIV) in reaction times across the trials of the Attention Network Test (ANT)
Attention Network Test (ANT) is a cognitive reaction time test administered on the computer, where the subject indicates when they see a target on a screen.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2018
- Study start1 Jul 2018
- Primary completion9 Jan 2021
- Study completion9 Jan 2021
Why it stopped: due to low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe 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
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Leigh Charvet, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03723356
- Sponsor's protocol ID
- 17-00238
- Status last verified
- Mar 2021
- First submitted
- 27 Sep 2018
- Last updated
- 26 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Linking Cognitive Functioning to Multimodal Imaging in Multiple Sclerosis
- ClinicalTrials.gov ID
- NCT03723356
- Acronym / sponsor ID
- 17-00238
- Conditions
- Multiple Sclerosis, Cognition Disorders
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: due to low enrollment
- Enrolment
- 6 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 9 Jan 2021 (actual)
- Study completion
- 9 Jan 2021 (actual)
- First posted
- 29 Oct 2018 (actual)
- 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.
Multiple sclerosis (MS) is the most common progressive neurologic disorder to occur in adults of working-age. Despite longstanding recognition of cognitive impairment as a symptom of MS, two obstacles in measurement have limited understanding its biological basis, and therefore identifying targeted options for management. First is the absence of a sensitive and precise measure of cognitive impairment. Second is the absence of an index of disease status linked to brain pathophysiology and cognitive performance. This project overcomes both obstacles to link cognitive impairment to MS disease biomarkers. The absence of a sensitive and precise measure of cognitive impairment, along with the absence of an index of disease status linked to brain pathophysiology and cognitive performance, limits the understanding of the biological basis for multiple sclerosis (MS). This project overcomes both obstacles to link cognitive function to MS disease biomarkers, and provides preliminary evaluation of a disease modifying therapy (Tecfidera) for preserving cognitive function.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MS Patients | – | Diagnostic Test: Siemens Biograph mMR (molecular MR), Diagnostic Test: fMRI, Diagnostic Test: Diffusion Spectrum Imaging (DSI)Definite diagnosis of RRMS |
| Healthy Controls | – | Diagnostic Test: Siemens Biograph mMR (molecular MR), Diagnostic Test: fMRI, Diagnostic Test: Diffusion Spectrum Imaging (DSI)gender aged match healthy |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- 20 MS participants and 10 healthy controls. However, the data analysis is planned for 15 MS participants and 10 healthy control participants. It is expected that 15 MS subjects and 10 healthy controls will complete 12 months.
Key inclusion criteria (10 listed)
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations.
- Male and Female subjects between 18 and 45 years
- WRAT-4 Reading [127] standard score > 85
- Able to undergo neuroimaging data collection procedures. For MS Participants
- Definite diagnosis of RRMS [128]
Key exclusion criteria (10 listed)
- Unable or unwilling to provide informed consent.
- Beck Depression Inventory-Fast Screen (BDI-FS) [129, 130] score of 4 or more
- Current alcohol or other substance use disorder
- Primary psychiatric disorder that would adversely influence ability to participate
- Other neurological condition associated with cognitive impairment (e.g., epilepsy, brain injury)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Siemens Biograph mMR (molecular MR)5mCi of the radiotracer FDG administered intravenously as a bolus over 30s. After injection, emission data will be collected for 60 min, | Diagnostic test | Healthy Controls, MS Patients |
| fMRIHigh-resolution T1-weighted structural image will be acquired using an MP2RAGE sequence. Subject will beasked to look at the cross hair on a screen andnot fixate on any one thought. | Diagnostic test | Healthy Controls, MS Patients |
| Diffusion Spectrum Imaging (DSI)DSI allows for more accurate characterization of diffusion,overcomes traditional dMRI artifacts, and is capable of more precise and detailedcharacterization of white matter fibers | Diagnostic test | Healthy Controls, MS Patients |
Primary outcome
intraindividual variation (ie IIV) in reaction times across the trials of the Attention Network Test (ANT)
Time frame: Baseline
Attention Network Test (ANT) is a cognitive reaction time test administered on the computer, where the subject indicates when they see a target on a screen.
intraindividual variation (ie IIV) in reaction times across the trials of the Attention Network Test (ANT)
Time frame: 3 Months
Attention Network Test (ANT) is a cognitive reaction time test administered on the computer, where the subject indicates when they see a target on a screen.
intraindividual variation (ie IIV) in reaction times across the trials of the Attention Network Test (ANT)
Time frame: 6 Months
Attention Network Test (ANT) is a cognitive reaction time test administered on the computer, where the subject indicates when they see a target on a screen.
intraindividual variation (ie IIV) in reaction times across the trials of the Attention Network Test (ANT)
Time frame: 9 Months
Attention Network Test (ANT) is a cognitive reaction time test administered on the computer, where the subject indicates when they see a target on a screen.
intraindividual variation (ie IIV) in reaction times across the trials of the Attention Network Test (ANT)
Time frame: 12 Months
Attention Network Test (ANT) is a cognitive reaction time test administered on the computer, where the subject indicates when they see a target on a screen.
Results and safety
The study was stopped early (reason given: due to low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
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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.
Leigh Charvet principal investigator
NYU Langone Health
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 and Cognition Disorders, run by NYU Langone Health 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 10 inclusion and 10 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: stopped early, as of the sponsor's last update on 26 Mar 2021. 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 was stopped early (reason given: due to low enrollment). Results are not available in the source record.
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?
intraindividual variation (ie IIV) in reaction times across the trials of the Attention Network Test (ANT) (time frame: Baseline). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Mar 2021.