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ENROLLING BY INVITATION

NCT03232463

Study for the Evaluation of the Feasibility of Applying Advanced MRI Scanning in Clinical Practice

Sponsor: Neurological Associates of West Los Angeles

View on ClinicalTrials.gov

Summary

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.

Official title: Open Label Study for the Evaluation of the Feasibility of Applying Advanced MRI Scanning in Clinical Practice

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

OBSERVATIONAL

Enrollment

2000

Start Date

2016-06-14

Completion Date

2030-12

Last Updated

2023-03-24

Healthy Volunteers

Conditions

Functional Magnetic Resonance Imaging

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

Locations (1)

Neurological Associates of West Los Angeles

Santa Monica, California, United States