Clinical trial NCT03723356: Linking Cognitive Functioning to Multimodal Imaging in Multiple Sclerosis (MS)
Official title: Linking Cognitive Functioning to Multimodal Imaging in Multiple Sclerosis
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Multiple Sclerosis
Cognition Disorders
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2018-10-29
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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 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.


Eligibility criteria: Inclusion Criteria:

1. 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.
2. Male and Female subjects between 18 and 45 years
3. WRAT-4 Reading \[127\] standard score \> 85
4. Able to undergo neuroimaging data collection procedures. For MS Participants
5. Definite diagnosis of RRMS \[128\]
6. EDSS of 0 to 6.0
7. Adequate vision as as reported by the participant (with correction if applicable)
8. Clinically prescribed Tecfidera, Tysabri or Ocrevus therapy by treating neurologist, with first dose being within 3 months + 14 days from baseline visit
9. At baseline visit, concurrent medications to be kept constant over three months prior to data collection visits
10. No relapse or steroids in previous month

Exclusion Criteria:

1. Unable or unwilling to provide informed consent.
2. Beck Depression Inventory-Fast Screen (BDI-FS) \[129, 130\] score of 4 or more
3. Current alcohol or other substance use disorder
4. Primary psychiatric disorder that would adversely influence ability to participate
5. Other neurological condition associated with cognitive impairment (e.g., epilepsy, brain injury)
6. Other serious uncontrolled medical condition (e.g., cancer or acute myocardial infarction)
7. Learned English language after 12 years of age
8. For low absolute low lymphocyte count (ALC), USPI guidance will be utilized.

   For MS participants:
9. Lemtrada, Cladribine, Mitoxantrone

Primary outcomes:
measure: intraindividual variation (ie IIV) in reaction times across the trials of the Attention Network Test (ANT)
timeFrame: Baseline
measure: intraindividual variation (ie IIV) in reaction times across the trials of the Attention Network Test (ANT)
timeFrame: 3 Months
measure: intraindividual variation (ie IIV) in reaction times across the trials of the Attention Network Test (ANT)
timeFrame: 6 Months
measure: intraindividual variation (ie IIV) in reaction times across the trials of the Attention Network Test (ANT)
timeFrame: 9 Months
measure: intraindividual variation (ie IIV) in reaction times across the trials of the Attention Network Test (ANT)
timeFrame: 12 Months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Leigh Charvet
role: PRINCIPAL_INVESTIGATOR
References: