Clinical trial NCT02118298: Allocentric Memory in MS and Resting State Functional MRI
Official title: Allocentric Memory as a Novel Measure of Cognitive Inefficiency: Sensitivity in Multiple Sclerosis (MS) Subjects and Relationship With Resting State Functional MRI
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2014-04-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with relapsing remitting Multiple Sclerosis and demographically matched controls will be recruited for this study. The MS subjects will consist of patients who were referred for a neuropsychological evaluation and neuroimaging as part of standard practice of care to evaluate for cognitive difficulties and/or track disease progression.

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.

Eligibility criteria: 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

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

Primary outcomes:
measure: Minimal Assessment of Cognitive Function in MS (MACFIMS)
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Franklin C Brown, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: