Linking Cognitive Functioning to Multimodal Imaging in Multiple Sclerosis (MS)

Multiple Sclerosis Clinical Trial

Official title:

Linking Cognitive Functioning to Multimodal Imaging in Multiple Sclerosis

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03723356
• Other study ID #: 17-00238
• Status: Terminated
• Start date: July 1, 2018
• Est. completion date: January 9, 2021

Study information

• Verified date: March 2021
• Source: NYU Langone Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: January 9, 2021
• Est. primary completion date: January 9, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognition Disorders
• Multiple Sclerosis
• Sclerosis

Intervention

Diagnostic Test:
• 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,
• fMRI
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)
DSI allows for more accurate characterization of diffusion,overcomes traditional dMRI artifacts, and is capable of more precise and detailedcharacterization of white matter fibers

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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