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Allocentric Memory in MS and Resting State Functional MRI

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Yale University

Status

Completed

Conditions

Multiple Sclerosis

Study type

Observational

Funder types

Other

Identifiers

NCT02118298
1401013272

Details and patient eligibility

About

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.

Full 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.

Enrollment

120 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

120 participants in 2 patient groups

Multiple Sclerosis
Description:
Ages 18 - 66, 10 years or less of MS,
Demographically matched controls
Description:
Ages 18 - 66, No known neurological disorder, no learning disorder, and no psychiatric disturbance that is actually interfering with life.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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