Multiple SclerosisNCT02118298
Allocentric Memory in MS and Resting State Functional MRI
An observational study of Multiple Sclerosis, run by Yale University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Multiple Sclerosis
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to Apr 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Multiple Sclerosis
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Franklin C Brown, Ph.D., Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02118298
- Sponsor's protocol ID
- 1401013272
- Status last verified
- May 2016
- First submitted
- 16 Apr 2014
- Last updated
- 13 May 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allocentric Memory as a Novel Measure of Cognitive Inefficiency: Sensitivity in Multiple Sclerosis (MS) Subjects and Relationship With Resting State Functional MRI
- ClinicalTrials.gov ID
- NCT02118298
- Acronym / sponsor ID
- 1401013272
- Conditions
- Multiple Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 21 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2016.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franklin C Brown, Ph.D. principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Multiple Sclerosis, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimal Assessment of Cognitive Function in MS (MACFIMS) (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2016.