Neurodevelopmental DisordersNCT03232489
Study for the Evaluation of the Feasibility of Applying Advanced MRI Scanning in Pediatric Clinical Practice
An observational study of Neurodevelopmental Disorders, run by Neurological Associates of West Los Angeles at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neurodevelopmental Disorders
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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 neonates to 18 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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 53Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Neurological Associates of West Los Angeles
Santa Monica, California, 90403
Ann Green
About this study
Official title: Open Label Study for the Evaluation of the Feasibility of Applying Advanced MRI Scanning in Pediatric Clinical Practice
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:
- The total time of the scan, including:
Read more
- 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.)
- Patient dropout rate, including:
- Change of mind
- Cost of study is too much
- Failure to finish the scan
- 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.
Read the 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 areas in three-dimensional space.
- Resting BOLD - BOLD stands for blood oxygen level dependent. This functional sequence allows for the viewing of the thinking brain at rest, and looks at brain areas that are functionally working together at the same time. The brain is in one of its most active states when it is at rest, and literature has shown that a few neurological illnesses such as OCD, depression, and pain have been associated with analyzing the data in this sequence.
- Arterial Spin Labeling (ASL) - ASL tracks the blood flow in the brain visually and gives a statistical value of how much blood is in each region in cc's per 100 grams of brain per second.
- Diffusion Tensor Imaging (DTI) - DTI tractography shows the different fiber tracts in the brain using a 3D model. Fiber tracts are the physical neural pathways that can show disruption or connection in communication between different areas of the brain. This is an effective technique when looking at traumatic brain injury.
- Magnetic Resonance Spectroscopy (MRS) - MRS measures the ratios of select chemical compounds in the brain in relation to each other. This has shown to be effective in analyzing memory loss, dementia, and Alzheimer's type disorders.
- Stimulated BOLD - The same sequence as the resting BOLD, except the brain is being scanned during the completion of a task, instead of rest. By specifying the task (visual, problem solving, language, etc.), the different areas of the brain working together to complete this task can be imaged. This is very effective for task-specific symptoms and deficits.
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.
- Conditions
- Neurodevelopmental Disorders
- Medical subject headings
- Neurodevelopmental Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 1 year
Secondary outcomes (10)
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.
Measured: Through study completion, an average of 1 year
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study startJul 2016
- Primary completionJan 2025 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurodevelopmental DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Neurological Associates of West Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sheldon Jordan, Neurological Associates of West Los Angeles
- Investigators
- Sheldon Jordan, MD, FAAN, Principal investigator, Neurological Associates of West Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03232489
- Sponsor's protocol ID
- 20161363
- Status last verified
- Sep 2022
- First submitted
- 12 Jun 2017
- Last updated
- 28 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Study for the Evaluation of the Feasibility of Applying Advanced MRI Scanning in Pediatric Clinical Practice
- ClinicalTrials.gov ID
- NCT03232489
- Acronym / sponsor ID
- 20161363
- Conditions
- Neurodevelopmental Disorders
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Neurological Associates of West Los AngelesUniversity, hospital or other
- Study start
- Jul 2016
- Primary completion
- Jan 2025 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 28 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.)
- Patient dropout rate, including:
- Change of mind
- Cost of study is too much
- Failure to finish the scan
- 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.
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 areas in three-dimensional space.
- Resting BOLD - BOLD stands for blood oxygen level dependent. This functional sequence allows for the viewing of the thinking brain at rest, and looks at brain areas that are functionally working together at the same time. The brain is in one of its most active states when it is at rest, and literature has shown that a few neurological illnesses such as OCD, depression, and pain have been associated with analyzing the data in this sequence.
- Arterial Spin Labeling (ASL) - ASL tracks the blood flow in the brain visually and gives a statistical value of how much blood is in each region in cc's per 100 grams of brain per second.
- Diffusion Tensor Imaging (DTI) - DTI tractography shows the different fiber tracts in the brain using a 3D model. Fiber tracts are the physical neural pathways that can show disruption or connection in communication between different areas of the brain. This is an effective technique when looking at traumatic brain injury.
- Magnetic Resonance Spectroscopy (MRS) - MRS measures the ratios of select chemical compounds in the brain in relation to each other. This has shown to be effective in analyzing memory loss, dementia, and Alzheimer's type disorders.
- Stimulated BOLD - The same sequence as the resting BOLD, except the brain is being scanned during the completion of a task, instead of rest. By specifying the task (visual, problem solving, language, etc.), the different areas of the brain working together to complete this task can be imaged. This is very effective for task-specific symptoms and deficits.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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 neonates to 18 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (53 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of subjects who successfully complete an fMRI scan
Time frame: Through study completion, an average of 1 year
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.
10 secondary outcomes
Subject appointment time vs. subject arrival time
Time frame: Through study completion, an average of 1 year
Time it takes subject to get from checked-in to start of scan (in minutes)
Time frame: Through study completion, an average of 1 year
How long was the scanner unoccupied (in minutes)
Time frame: Through study completion, an average of 1 year
Number and type of sequences performed
Time frame: Through study completion, an average of 1 year
Time of scan (in minutes)
Time frame: 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)
Time frame: Through study completion, an average of 1 year
Did the subject finish the scan
Time frame: Through study completion, an average of 1 year
Did the subject cancel the scan, and for what reason
Time frame: Through study completion, an average of 1 year
Did the subject cause too much movement artifact
Time frame: Through study completion, an average of 1 year
Does the subject need to be re-scanned, and for what reason
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sheldon Jordan, MD, FAAN principal investigator
Neurological Associates of West Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurodevelopmental Disorders, run by Neurological Associates of West Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 53 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sheldon Jordan, MD, FAAN (3108295968, shellyj@aol.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects who successfully complete an fMRI scan (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2022.