Recruiting

MRI

Sponsor:

Neurological Associates of West Los Angeles

Code:

NCT03232489

Conditions

Neurodevelopmental Disorders

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

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 evaluate the studies of pediatric patients who 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, i.e. 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 two to five 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 a 1.5 Tesla Siemens MRI scanner at Westwood Open MRI, a 3 Tesla GE scanner at Tower Saint John's Imaging, or a 3 Tesla Siemens MRI scanner at Resolution Imaging. All scanners are FDA-approved.

Conditions

Neurodevelopmental Disorders

Study ID

NCT03232489

Start date

Jul, 2016

Status verified date

Sep, 2022

Completion date

Jan, 2025

Anticipated

Primary completion date

Jan, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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 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 Criteria:

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

Study Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Number of subjects who successfully complete an fMRI scan [ Time Frame: Through study completion, an average of 1 year ]

Central Contacts and Locations

Central contacts

Locations

Neurological Associates of West Los Angeles

Recruiting

Santa Monica, California, United States, 90403

More Information

Sponsor

Neurological Associates of West Los Angeles

Last update posted

Sep 28, 2022

Last verified

Sep, 2022

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Neurological Associates of West Los Angeles on 2022-09-28.