Allocentric Memory in MS and Resting State Functional MRI

NCT ID: NCT02118298

Last Updated: 2016-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-04-30

Study Completion Date

2016-04-30

Brief Summary

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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

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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.

Conditions

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Multiple Sclerosis

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Multiple Sclerosis

Ages 18 - 66, 10 years or less of MS,

No interventions assigned to this group

Demographically matched controls

Ages 18 - 66, No known neurological disorder, no learning disorder, and no psychiatric disturbance that is actually interfering with life.

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Yale University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Franklin C Brown, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

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Yale University

New Haven, Connecticut, United States

Site Status

Countries

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United States

Other Identifiers

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1401013272

Identifier Type: -

Identifier Source: org_study_id

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