Allocentric Memory in MS and Resting State Functional MRI

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT02118298
• Lead Sponsor: Yale University

Brief Summary

The goals of this study are to 1. Investigate the sensitivity of allocentric visual memory when compared to more established measures of cognition in identifying cognitive difficulties among MS subjects when compared to controls. 2. Determine which cognitive test variable will be most strongly associated with self and informant reports of cognition. 3. Determine which MRI metric will be most strongly related to neuropsychological test performance 4. Determine the degree to which allocentric visual memory is related to functional connectivity on fMRI.

Detailed Description

This is a cross-sectional, case-control, observational experimental design. The study will enroll subjects with multiple sclerosis (MS) and age/gender matched on a battery of neuropsychological cognitive tests and self-report measures of cognition.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-16
• Study First Submitted QC: 2014-04-16
• Study First Posted: 2014-04-21
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-11
• Last Update Posted: 2016-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• 18-55 years old
• Right handed
• Capacity to provide informed consent and sign consent
• Diagnosis of Relapsing Remitting MS that meets the revised McDonald Criteria (2010) within the last 10 years
• EDSS 0- 5.5

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Exclusion Criteria

• Diagnosis of primary progressive MS
• Contraindications for MRI
• Subjects required to take medications known to either benefit or adversely affect cognition at the time of testing and impact neuroimaging
• Non-MS neurological disorders
• Other medical or psychiatric disorders likely to affect cognitive performance
• Active immunodeficiency, chronic infections, or history or progressive multifocal leukoencephalopathy
• Individuals with severe level of depression on the BDI-II or severe anxiety on the BAI
• MS subjects who are actively experiencing acute exacerbation in symptoms and they must be at least 4 weeks free of steroid medication, are currently taking a chemotherapy agent, or have changed medication in the last two months
• Subjects who fail symptom validity measures during neuropsychological testing will be excluded

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Minimal Assessment of Cognitive Function in MS (MACFIMS)	Baseline	The MACFIMS is composed of seven neuropsychological tests, covering five cognitive domains commonly impaired in MS (processing speed/working memory, learning and memory, executive function, visual-spatial processing and word retrieval)

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States