Allocentric Memory in MS and Resting State Functional MRI

Multiple Sclerosis Clinical Trial

Official title:

Allocentric Memory as a Novel Measure of Cognitive Inefficiency: Sensitivity in Multiple Sclerosis (MS) Subjects and Relationship With Resting State Functional MRI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02118298
• Other study ID #: 1401013272
• Status: Completed
• Phase: N/A
• First received: April 16, 2014
• Last updated: May 11, 2016
• Start date: April 2014
• Est. completion date: April 2016

Study information

• Verified date: May 2016
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No