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

Terminated

• Conditions: Cognition Disorders; Multiple Sclerosis
• Interventions: Diagnostic Test: Siemens Biograph mMR (molecular MR); Diagnostic Test: fMRI; Diagnostic Test: Diffusion Spectrum Imaging (DSI)

• Registration Number: NCT03723356
• Lead Sponsor: NYU Langone Health

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-01
• Study First Submitted: 2018-09-27
• Study First Submitted QC: 2018-10-25
• Study First Posted: 2018-10-29
• Primary Completion: 2021-01-09
• Study Completion: 2021-01-09
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-24
• Last Update Posted: 2021-03-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy Controls	fMRI	gender aged match healthy
MS Patients	Siemens Biograph mMR (molecular MR)	Definite diagnosis of RRMS
Healthy Controls	Diffusion Spectrum Imaging (DSI)	gender aged match healthy
MS Patients	fMRI	Definite diagnosis of RRMS
MS Patients	Diffusion Spectrum Imaging (DSI)	Definite diagnosis of RRMS
Healthy Controls	Siemens Biograph mMR (molecular MR)	gender aged match healthy

Primary Outcome Measures

Name	Time	Method
intraindividual variation (ie IIV) in reaction times across the trials of the Attention Network Test (ANT)	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.

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States