Traumatic Brain InjuryNCT02728960
Traumatic Brain Injury Biological Diagnosis Via High Definition Tractography Asymmetry Screening
A study testing MRI of the Brain (No Contrast) Scan in people with Traumatic Brain Injury, run by NYU Langone Health.
Trial summary
The primary purpose of this study is to validate the High Definition Fiber Tracking (HDFT/HDFTAS) technology, so that faster, more reliable diagnosis can be implemented in Traumatic Brain Injury (TBI). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- What is being tested?
- MRI of the Brain (No Contrast) Scan
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Dec 2018
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Documented history of TBI (for Chronic).
- No MRI contraindications such as implanted ferrous metal, pacemakers, body weight above 125 Kg, (might not fit in the scanner), or concerns about claustrophobia.
- No prior history of concussion, TBI, blast exposure, stroke, or other major neurological disorder.
- No MRI contraindications such as implanted ferrous metal, pacemakers, body weight above 125 Kg, (might not fit in the scanner), or concerns about claustrophobia.
- No MRI contraindications such as implanted ferrous metal, pacemakers, body weight above 125 Kg, (might not fit in the scanner), or concerns about claustrophobia.
Who cannot join
- Inability or unwillingness of subject to provide written informed consent.
- History of penetrating gunshot wound.
- Inability or unwillingness of subject to provide written informed consent.
- History of concussions, stroke, or penetrating gunshot wound.
- Inability or unwillingness of subject to provide written informed consent
- Contra-indication to MR imaging, such as ferrous metal, pacemakers, body weight above 125 Kg or concerns
About this study
Official title: TBI Biological Diagnosis Via High Definition Tractography Asymmetry Screening
The primary purpose of this study is to validate the High Definition Fiber Tracking (HDFT/HDFTAS) technology, so that faster, more reliable diagnosis can be implemented in Traumatic Brain Injury (TBI). This study will involve Traumatic Brain Injury Patients and normal controls, in addition to 30 pilot participants who will be undergoing MRI in order to develop a statistically sound range for the metrics derived from HDFT.
Read the detailed description
This descriptive study sponsored by the United States Department of Defense involves the examination of TBI participants and normal control participants through MRI (Without Contrast) scanning. Normal controls are essential to develop a statistically sound range for the metrics derived from High Definition Fiber Tracking (HDFT). TBI subjects will undergo 1 MRI scan and normal controls will be asked to undergo 1 MRI scan. The study will involve blinded evaluations of results to determine the ability of HDFT imaging methods to evaluate TBI.
In addition to the TBI and normal controls evaluated in this research study, investigators will be running 30 pilot participants. These participants will be undergoing MRI in order to streamline our pulse sequence and calibrate the MRIs. This is part of the technical development for the project and will occur before the recruitment of TBI subjects and normal controls for comparison. Data from the pilot subjects will not serve as control data for the TBI subjects.
- Conditions
- Traumatic Brain Injury
- Being tested
- MRI of the Brain (No Contrast) Scan
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRI of the Brain (No Contrast) ScanProcedure or surgery
DSI data will be acquired on 3T Tim Trio System (Siemens) using a 32-channel coil
| Study group | Role | What they receive |
|---|---|---|
| Traumatic Brain Injury | Experimental | Documented history of Traumatic Brain Injury Receives: Procedure: MRI of the Brain (No Contrast) Scan |
| Normal Controls | Active comparator | No prior history of concussion, TBI, blast exposure, stroke, or other major neurological disorder Receives: Procedure: MRI of the Brain (No Contrast) Scan |
| Sequence Development Volunteers | Active comparator | Not described Receives: Procedure: MRI of the Brain (No Contrast) Scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diagnosis reliability measured by MRI scanning data results
Measured: 2 Hours
Amount of white matter damage using HDTAS DSI diffusion evaluation of volume and connectivity across 40 fiber tracts over 150 brain regions.
Tract anomalies will be coded as significant differences either to normative data of the tract or expected left/right ratio of tract axonal volume. White matter damage will first be quantified through HDFT evaluation of volume and connectivity across 40 fiber tracts over 150 brain regions
Measured: 2 Hours
Comparison of severity of subjects with TBI using Diffusion Tension Imaging (DTI)
Measured: 2 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2016 (estimated)
- Study startFeb 2015
- Primary completionDec 2018
- Study completionDec 2018
Why it stopped: Study under review. Temporarily suspended
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fernando Boada, PhD, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02728960
- Sponsor's protocol ID
- 12-03539
- Status last verified
- May 2019
- First submitted
- 8 Mar 2016
- Last updated
- 10 May 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TBI Biological Diagnosis Via High Definition Tractography Asymmetry Screening
- ClinicalTrials.gov ID
- NCT02728960
- Acronym / sponsor ID
- 12-03539
- Conditions
- Traumatic Brain Injury
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study under review. Temporarily suspended
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 6 Apr 2016 (estimated)
- 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 primary purpose of this study is to validate the High Definition Fiber Tracking (HDFT/HDFTAS) technology, so that faster, more reliable diagnosis can be implemented in Traumatic Brain Injury (TBI). This study will involve Traumatic Brain Injury Patients and normal controls, in addition to 30 pilot participants who will be undergoing MRI in order to develop a statistically sound range for the metrics derived from HDFT.
Detailed description
This descriptive study sponsored by the United States Department of Defense involves the examination of TBI participants and normal control participants through MRI (Without Contrast) scanning. Normal controls are essential to develop a statistically sound range for the metrics derived from High Definition Fiber Tracking (HDFT). TBI subjects will undergo 1 MRI scan and normal controls will be asked to undergo 1 MRI scan. The study will involve blinded evaluations of results to determine the ability of HDFT imaging methods to evaluate TBI.
In addition to the TBI and normal controls evaluated in this research study, investigators will be running 30 pilot participants. These participants will be undergoing MRI in order to streamline our pulse sequence and calibrate the MRIs. This is part of the technical development for the project and will occur before the recruitment of TBI subjects and normal controls for comparison. Data from the pilot subjects will not serve as control data for the TBI subjects.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Traumatic Brain Injury | Experimental | Procedure: MRI of the Brain (No Contrast) ScanDocumented history of Traumatic Brain Injury |
| Normal Controls | Active comparator | Procedure: MRI of the Brain (No Contrast) ScanNo prior history of concussion, TBI, blast exposure, stroke, or other major neurological disorder |
| Sequence Development Volunteers | Active comparator | Procedure: MRI of the Brain (No Contrast) Scan |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Documented history of TBI (for Chronic).
- No MRI contraindications such as implanted ferrous metal, pacemakers, body weight above 125 Kg, (might not fit in the scanner), or concerns about claustrophobia.
- No prior history of concussion, TBI, blast exposure, stroke, or other major neurological disorder.
- No MRI contraindications such as implanted ferrous metal, pacemakers, body weight above 125 Kg, (might not fit in the scanner), or concerns about claustrophobia.
- No MRI contraindications such as implanted ferrous metal, pacemakers, body weight above 125 Kg, (might not fit in the scanner), or concerns about claustrophobia.
Key exclusion criteria (6 listed)
- Inability or unwillingness of subject to provide written informed consent.
- History of penetrating gunshot wound.
- Inability or unwillingness of subject to provide written informed consent.
- History of concussions, stroke, or penetrating gunshot wound.
- Inability or unwillingness of subject to provide written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRI of the Brain (No Contrast) ScanDSI data will be acquired on 3T Tim Trio System (Siemens) using a 32-channel coil | Procedure or surgery | Normal Controls, Sequence Development Volunteers, Traumatic Brain Injury |
Primary outcome
Diagnosis reliability measured by MRI scanning data results
Time frame: 2 Hours
Amount of white matter damage using HDTAS DSI diffusion evaluation of volume and connectivity across 40 fiber tracts over 150 brain regions.
Time frame: 2 Hours
Tract anomalies will be coded as significant differences either to normative data of the tract or expected left/right ratio of tract axonal volume. White matter damage will first be quantified through HDFT evaluation of volume and connectivity across 40 fiber tracts over 150 brain regions
Comparison of severity of subjects with TBI using Diffusion Tension Imaging (DTI)
Time frame: 2 Hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
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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.
Fernando Boada, PhD principal investigator
New York University Medical School
Questions about this trial
What is this clinical trial studying?
A study testing MRI of the Brain (No Contrast) Scan in people with Traumatic Brain Injury, run by NYU Langone Health.
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 5 inclusion and 6 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: withdrawn, as of the sponsor's last update on 10 May 2019. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diagnosis reliability measured by MRI scanning data results (time frame: 2 Hours). The study lists 3 primary outcomes in all. 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 10 May 2019.