Study Stopped
due to low enrollment
due to low enrollment
Sponsor study identifier
observational
6
1 country
1
Study Start
July 1, 2018
Actual (reported)Primary Completion
January 9, 2021
Actual (reported)Study Completion
January 9, 2021
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 9, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 1, 2018
Actual (reported)September 27, 2018
Actual (reported)October 29, 2018
Actual (reported)January 9, 2021
Actual (reported)January 9, 2021
Actual (reported)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.
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.
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.
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.
9 Months
Definite diagnosis of RRMS
gender aged match healthy
5mCi of the radiotracer FDG administered intravenously as a bolus over 30s. After injection, emission data will be collected for 60 min,
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.
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.
New York University School of Medicine
New York, New York, 10016, United States
Leigh Charvet
NYU Langone Health
6 participants (actual enrollment reported by the registry).
First Submitted
September 27, 2018
First Posted
October 29, 2018
Study Start
July 1, 2018
Actual (reported)Intervention to Reduce Perceived Cognitive Impairment in Multiple Sclerosis
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.
12 Months
DSI allows for more accurate characterization of diffusion,overcomes traditional dMRI artifacts, and is capable of more precise and detailedcharacterization of white matter fibers
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
January 9, 2021
Actual (reported)Study Completion
January 9, 2021
Actual (reported)Last Updated
March 26, 2021
Record last verified: 2021-03
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices).
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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