Allocentric Memory in MS and Resting State Functional MRI

NCT02118298 | Completed

• 1 other identifier: 1401013272
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Minimal Assessment of Cognitive Function in MS (MACFIMS)

  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)

  Baseline

Study Arms (2)

Multiple Sclerosis

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

Demographically matched controls

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

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead

Study Sites (1)

Yale University

New Haven, Connecticut, 06520, United States

Location

MeSH Terms

Conditions

Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Franklin C Brown, Ph.D.

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2014
• First Posted: April 21, 2014
• Study Start: April 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: May 13, 2016

Record last verified: 2016-05

Locations

US (1)