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The purpose of this research study is to evaluate the feasibility in conducting advanced MRI sequences in a clinical setting. The study will be observational in nature, and will only evaluate the studies of patients that have already been prescribed an advanced MRI for clinical neurological purposes. The only difference for the subject in participating in this study is that the data and information about their scan can be used and disclosed for research purposes, which is understanding if the time of the scan, patient comfort, and quality of the data are feasible. Standard MRI's have been extremely beneficial in the diagnosis and assessment of disease, injury, and anomalies throughout the body. Adding advanced MRI sequences to the arsenal of current standard MRI sequences, as well as analyzing the clinical significance of the data, may improve the benefits of MRI in the future. Within this scope, the study will be looking at the following factors:
The total time of the scan, including:
Patient dropout rate, including:
Usability of data, including:
The scan will consist of several advanced MRI sequences that will average between 7-15 minutes each, in addition to a routine 5 minute standard MRI sequence. The variability in the number of advanced sequences depends on the prescription and patient history. All sequences are performed using an FDA-approved MRI scanner.
An MPRAGE is a high quality anatomical image of the brain. This is used as an anatomical overlay, so that all data collected from the advanced sequences below can be correlated with the correct brain areas in three dimensional space.
The methods and procedures in this study are all under the observational category. MRI's are FDA approved and are non-experimental devices. The goal of this research is to assess the feasibility of the scan itself, so everything done with respect to the scan is considered observational in nature. If the subject drops out of the study, anything described in this protocol will still be able available to the subject as standard medical care. The observational procedures will involve recording data for the advanced MRI scans, and no information will be shared for research if the subject does not sign the consent form.
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| Measure | Description | Time Frame |
|---|---|---|
| Number of subjects who successfully complete an fMRI scan | In order to assess scan feasibility, we will keep track of the total number of patients who sign the consent form and are able to complete the fMRI scan. | Through study completion, an average of 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Subject appointment time vs. subject arrival time | For each study subject, we will record the scheduled fMRI appointment time vs. the time that the subject arrives. | Through study completion, an average of 1 year |
| Time it takes subject to get from checked-in to start of scan (in minutes) |
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Inclusion Criteria:
In order for a subject to be considered for this study, the following criteria are required:
Exclusion Criteria:
In order for a subject to be considered for this study, he/she may NOT have any of the following items which cannot be removed prior to the MRI exam. A subject who can remove any of the following prior to the MRI exam will still be considered for the study.
As well as:
Any subjects from the following categories/groups will NOT be included in the study:
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The subjects in this research study will be recruited by routine medical office exam.The ages for the subjects in this study will range from 18 to 65 years old.The gender distribution for this study will aim for a ratio of 50:50 male to female. There are no enrollment restrictions based upon race or ethnic origin. There are also no additional benefits, risks, advantages, or disadvantages based off of any race or ethnic origin.
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| Name | Affiliation | Role |
|---|---|---|
| Sheldon Jordan, MD | Neurological Associates of West Los Angeles | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Neurological Associates of West Los Angeles | Santa Monica | California | 90403 | United States |
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For each study subject, we will record how long it takes to transition the subject from check-in to starting the fMRI scan. |
| Through study completion, an average of 1 year |
| How long was the scanner unoccupied (in minutes) | We will record the length of time that the scanner is unoccupied in between scans. | Through study completion, an average of 1 year |
| Number and type of sequences performed | For each study subject, we will record the number and type of sequences performed for the fMRI scan, e.g. MPRAGE, ASL, Resting BOLD, etc. | Through study completion, an average of 1 year |
| Time of scan (in minutes) | For each study subject, we will record the total amount of time it takes to complete the fMRI scan. | Through study completion, an average of 1 year |
| How many times did the subject pause the scan (if any) and for how long (in minutes) | For each study subject, we will record the number of times a subject pauses the fMRI scan and the duration of each pause. | Through study completion, an average of 1 year |
| Did the subject finish the scan | For each study subject, we will record whether or not the subject was able to complete the fMRI scan. | Through study completion, an average of 1 year |
| Did the subject cancel the scan, and for what reason | For each study subject, we will record whether the patient canceled the fMRI scan and for what reason. | Through study completion, an average of 1 year |
| Did the subject cause too much movement artifact | For each study subject, we will record whether the post-processed fMRI data shows too much motion artifact, which could lead to the subject needing to be re-scanned. | Through study completion, an average of 1 year |
| Does the subject need to be re-scanned, and for what reason | For each study subject, we will record whether or not the subject requires a re-scan and for what reason. | Through study completion, an average of 1 year |