- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02118298
Allocentric Memory in MS and Resting State Functional MRI
May 11, 2016 updated by: Yale University
Allocentric Memory as a Novel Measure of Cognitive Inefficiency: Sensitivity in Multiple Sclerosis (MS) Subjects and Relationship With 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.
Study Overview
Status
Completed
Conditions
Detailed 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.
Study Type
Observational
Enrollment (Actual)
120
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Connecticut
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New Haven, Connecticut, United States, 06520
- Yale University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
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.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Multiple Sclerosis
Ages 18 - 66, 10 years or less of MS,
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Demographically matched controls
Ages 18 - 66, No known neurological disorder, no learning disorder, and no psychiatric disturbance that is actually interfering with life.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Minimal Assessment of Cognitive Function in MS (MACFIMS)
Time Frame: Baseline
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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)
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Baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Franklin C Brown, Ph.D., Yale University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2014
Primary Completion (Actual)
April 1, 2016
Study Completion (Actual)
April 1, 2016
Study Registration Dates
First Submitted
April 16, 2014
First Submitted That Met QC Criteria
April 16, 2014
First Posted (Estimate)
April 21, 2014
Study Record Updates
Last Update Posted (Estimate)
May 13, 2016
Last Update Submitted That Met QC Criteria
May 11, 2016
Last Verified
May 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1401013272
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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