Functional Magnetic Resonance Imaging Clinical Trial
Official title:
Open Label Study for the Evaluation of the Feasibility of Applying Advanced MRI Scanning in Clinical Practice
Verified date | March 2023 |
Source | Neurological Associates of West Los Angeles |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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: 1. The total time of the scan, including: - Patient arrival time/lateness - Patient preparation time - Time scanner is being occupied - Patient compliance (is the patient continually stopping the study for breaks, fear, movement, etc) 2. Patient dropout rate, including: - Change of mind - Cost of study is too much - Failure to finish the scan 3. Usability of data, including: - Movement artifact - Patient requiring re-scan for any reason 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.
Status | Enrolling by invitation |
Enrollment | 2000 |
Est. completion date | December 2030 |
Est. primary completion date | December 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: In order for a subject to be considered for this study, the following criteria are required: - The subject is between the ages of 18-65 years old. - The subject clinically needs an advanced MRI - The subject has consented for his/her self. - The subject is fluent in the English language. - The subject is proficient in comprehending verbal and written English. 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. - Aneurism clips - Cardiac pacemaker - Implanted cardioinverter defibrillator - Electronic implant or device - Magnetically activated implant or device - Neurostimulation system - Spinal cord stimulator - Internal electrodes or wires - Bone growth/bone fusion stimulator - Cochlear, otologic, or other ear implant - Insulin or other infusion pump - Implanted drug infusion device - Any type of prosthesis (eye, penile, etc.) - Heart valve prosthesis - Eyelid spring or wire - Artificial or prosthetic limb - No Metallic stent, filter, or coil - Shunt (spinal or intraventricular) - Vascular access port and/or catheter - Radiation seeds or implants - Swan-Ganz or thermodilution catheter - Medication patch (Nicotine, Nitroglycerine) - Any metallic fragment or foreign body - Wire mesh implant - Tissue expander (e.g., breast) - Surgical staples, clips, or metallic sutures - Joint replacement (hip, knee, etc.) - Bone/joint pin, screw, nail, wire, plate, etc. - IUD, diaphragm, or pessary - Dentures or partial plates - Tattoo or permanent makeup - Body piercing jewelry - Hearing aid As well as: - Breathing problem or motion disorder - Severe claustrophobia Any subjects from the following categories/groups will NOT be included in the study: - Prisoners - Minors - Poor/uninsured - Institutionalized - Limited or non-readers - Non-English speaking subjects - Wards of the state - Pregnant women - Nursing home residents recruited in the nursing home - Students of PI or study staff - Students recruited in the educational setting (school, class, etc) - Employees directly supervised by the PI or sub-investigator - Employees of research site or sponsor - Military personnel recruited by military personnel - Cognitively impaired - Adult subjects that cannot consent for themselves |
Country | Name | City | State |
---|---|---|---|
United States | Neurological Associates of West Los Angeles | Santa Monica | California |
Lead Sponsor | Collaborator |
---|---|
Neurological Associates of West Los Angeles |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Secondary | 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 | |
Secondary | Time it takes subject to get from checked-in to start of scan (in minutes) | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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