Status:
UNKNOWN
Study for the Evaluation of the Feasibility of Applying Advanced MRI Scanning in Pediatric Clinical Practice
Lead Sponsor:
Neurological Associates of West Los Angeles
Conditions:
Neurodevelopmental Disorders
Eligibility:
All Genders
Brief Summary
The purpose of this research study is to evaluate the feasibility in conducting advanced MRI sequences in a pediatric clinical setting. The study will be observational in nature, and will only evaluat...
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- In order for a subject to be considered for this study, the following criteria are required:
- The subject is between the ages of neonate-18 years old
- The subject clinically needs an advanced MRI
- The assent of the subject and the agreement of parent(s) or guardian(s) to the participation of their child or ward in research, in accordance with the regulations set forth in the Belmont Report
Exclusion
- In order for a subject to be considered for this study, he/she may NOT have any of the following items in which cannot be removed prior to the MRI exam. A subject that 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
- 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
Key Trial Info
Start Date :
July 1 2016
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT03232489
Start Date
July 1 2016
End Date
January 1 2025
Last Update
September 28 2022
Active Locations (1)
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1
Neurological Associates of West Los Angeles
Santa Monica, California, United States, 90403