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OpenTrials
Completed

NCT Number: NCT02118298

Allocentric Memory in MS and Resting State Functional MRI

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.

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Key information

Conditions

Multiple Sclerosis Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Nervous System Diseases

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Yale University

New Haven, Connecticut, 06520, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Minimal Assessment of Cognitive Function in MS (MACFIMS)

    Time frame: Baseline

    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)

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 21, 2014
Registry last updated
May 13, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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