Mild Traumatic Brain InjuryTBINCT02070588
Advanced MRI Applications for Mild Traumatic Brain Injury
A study testing MRI in people with Mild Traumatic Brain Injury and Traumatic Brain Injury, run by GE Healthcare at 1 site in United States.
Trial summary
This feasibility study is being conducted to determine potential associations between a broad range of clinical neurological symptoms and magnetic resonance images (MRI), data, and clinical findings involved in mild traumatic brain injury (mTBI). Read more about this study
- Who is it for?
- Ages 15 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Traumatic Brain Injury, Traumatic Brain Injury
- What is being tested?
- MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Nov 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 15 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- All included subjects will:
- Aged ≥15 and ≤50 years old at the time of enrollment;
- Be well matched to one or more mTBI patients in Segment 1, in the opinion of the Principal Investigator, with regards to:
- Age,
- Gender,
- Sociodemographic characteristics, and
- Handedness.
- Be capable of sufficiently clear communication to allow the subject to provide written informed consent, or assent with parental or guardian consent for minors as described in Section 6.3 - Protection of Vulnerable Subjects, for participation in all parts of the study.
Who cannot join
- Subjects will be excluded that:
- Are currently pregnant based on subject self-report of pregnancy status;
- Are currently enrolled in another Segment of this study;
- Require medical care that would be adversely affected or delayed by participating, in the opinion of a physician investigator;
- Prior diagnosis of mild TBI within the past 12 months;
- Have structural brain injury indicated by previous neuroimaging findings;
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- Previous history of moderate to severe TBI within the past 10 years;
- Previously diagnosed brain white matter disease;
- History of seizures within the past 10 years;
- History of illicit drug abuse (except marijuana) within the past 10 years
- History of alcohol abuse or dependence (per DSM-IV-TR Diagnostic Criteria);
- Current primary Axis I or II psychiatric disorders, except for disorders classified as minor and not expected to impact study conduct or integrity (as detailed in Appendix D - Screening for Exclusion based on Axis I or II Disorders):
- History of brain mass;
- History of neurosurgery;
- History of stroke;
- History of dementia;
- Known cognitive dysfunction;
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 08540
About this study
This feasibility study is being conducted to determine potential associations between a broad range of clinical neurological symptoms and magnetic resonance images (MRI), data, and clinical findings involved in mild traumatic brain injury (mTBI).
These associations will be examined over the acute and sub-acute period (approximately 3 months) following injury to provide information useful for optimization of MR pulse sequences for mTBI applications.
Correlations exist over the sub-acute period in clinical neurological and MR data (images, image reads, and RAW data), which may indicate temporal evolution patterns. The intent of this study is to broadly generate potential biomarkers of temporal evolution of mTBI detectable in MR images and data ("MR mTBI biomarkers").
Read the detailed description
This hypothesis-generating feasibility study is being conducted to determine potential associations between a broad range of clinical neurological symptoms and MR images, data, and clinical findings involved in mild traumatic brain injury (mTBI). These associations will be examined over the acute and sub-acute period (approximately 3 months) following injury to provide information useful for optimization of MR pulse sequences for mTBI applications.
The intent of this study is to broadly generate a range of potential mTBI biomarkers detectable using investigational MR pulse sequence technologies. Feasibility data attained in this study may be used for engineering program decision-making and in support of future scientific assessment, engineering development, published research databases or registries mTBI data and images, and other purposes determined by the Sponsor. The results of this study are not intended for use in regulatory submissions.
Subjects will be examined on commercially available MR scanners using investigational or standard of care MR coils and a series of investigational MR Pulse Sequence sets (Application Packs). Each Application Pack will consist of a predetermined sequence of investigational pulse sequences (IPSs) optimized by GE Healthcare (GEHC) for mTBI. IPSs will be administered in a predetermined order as part of each Application Pack.
- Being tested
- MRI
- Keywords
- TBI, mTBI, MR, MRI, Pulse Sequences, NFL
- Medical subject headings
- Brain Concussion, Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
Also called Discovery MR750 & Discovery MR750w scanners, Investigation software, Comericial nuerological coil (3T Advanced Neurological (Brain) Array MR Coil)
MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Diagnostic mTBI | Active comparator | MRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI) Receives: Device: MRI |
| Experimental: Diagnostic Non mTBI | Placebo comparator | MRI Diagnostic of Non injured subjects that are closely matched to mTBI Receives: Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
mTBI Progression Indicated by Clinical Neurological Characteristics, MRI Images, and Quantitative MRI Data From Novel Software
To determine associations between clinical neurological data, MR images, quantitative data from novel software post-processing (sponsor developed software including volumetry, Resting State [RS] functional magnetic resonance imaging [fMRI], kurtosis).
Measured: Per-patient 1 to 3 months, until dataset completion 1 yr
Secondary outcomes (2)
Subject Demographics
To comprehensively collect subject information (i.e. baseline health data, demographics, socioeconomics, injury presentation, post-injury status, and injury type, place, and cause) for mTBI subjects in context of MRI data.
Measured: Per-patient 1 to 3 months, until dataset completion 1 yr
Operator Set MRI Parameters
To record operator-adjusted parameters of the novel software on the MRI system
Measured: Per-patient 1 to 3 months, until dataset completion 1 yr
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionJun 2015
- Study completionNov 2015
Why it stopped: Sponsor terminated early as moving to a new larger study program
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Mild Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Teena Shetty, MD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02070588
- Sponsor's protocol ID
- 114-2013-GES-0017
- Acronym
- TBI
- Status last verified
- Jun 2017
- First submitted
- 18 Feb 2014
- Last updated
- 21 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced MRI Applications for Mild Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT02070588
- Acronym / sponsor ID
- TBI / 114-2013-GES-0017
- Keywords
- TBI, mTBI, MR, MRI, Pulse Sequences, NFL
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor terminated early as moving to a new larger study program
- Enrolment
- 112 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Study start
- Feb 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 25 Feb 2014 (estimated)
- Results
- Posted 21 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This feasibility study is being conducted to determine potential associations between a broad range of clinical neurological symptoms and magnetic resonance images (MRI), data, and clinical findings involved in mild traumatic brain injury (mTBI).
These associations will be examined over the acute and sub-acute period (approximately 3 months) following injury to provide information useful for optimization of MR pulse sequences for mTBI applications.
Correlations exist over the sub-acute period in clinical neurological and MR data (images, image reads, and RAW data), which may indicate temporal evolution patterns. The intent of this study is to broadly generate potential biomarkers of temporal evolution of mTBI detectable in MR images and data ("MR mTBI biomarkers").
Detailed description
This hypothesis-generating feasibility study is being conducted to determine potential associations between a broad range of clinical neurological symptoms and MR images, data, and clinical findings involved in mild traumatic brain injury (mTBI). These associations will be examined over the acute and sub-acute period (approximately 3 months) following injury to provide information useful for optimization of MR pulse sequences for mTBI applications.
The intent of this study is to broadly generate a range of potential mTBI biomarkers detectable using investigational MR pulse sequence technologies. Feasibility data attained in this study may be used for engineering program decision-making and in support of future scientific assessment, engineering development, published research databases or registries mTBI data and images, and other purposes determined by the Sponsor. The results of this study are not intended for use in regulatory submissions.
Subjects will be examined on commercially available MR scanners using investigational or standard of care MR coils and a series of investigational MR Pulse Sequence sets (Application Packs). Each Application Pack will consist of a predetermined sequence of investigational pulse sequences (IPSs) optimized by GE Healthcare (GEHC) for mTBI. IPSs will be administered in a predetermined order as part of each Application Pack.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Diagnostic mTBI | Active comparator | Device: MRIMRI Diagnostic of subjects with mild Tramatic Brain Injury (mTBI) |
| Experimental: Diagnostic Non mTBI | Placebo comparator | Device: MRIMRI Diagnostic of Non injured subjects that are closely matched to mTBI |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- Aged ≥15 and ≤50 years old at the time of enrollment;
- Be well matched to one or more mTBI patients in Segment 1, in the opinion of the Principal Investigator, with regards to:
- Be capable of sufficiently clear communication to allow the subject to provide written informed consent, or assent with parental or guardian consent for minors as described in Section 6.3 - Protection of Vulnerable Subjects, for participation in all parts of the study.
Key exclusion criteria (17 listed)
- Are currently pregnant based on subject self-report of pregnancy status;
- Are currently enrolled in another Segment of this study;
- Require medical care that would be adversely affected or delayed by participating, in the opinion of a physician investigator;
- Prior diagnosis of mild TBI within the past 12 months;
- Have structural brain injury indicated by previous neuroimaging findings;
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 |
|---|---|---|
| MRIAlso: Discovery MR750 & Discovery MR750w scanners, Investigation software, Comericial nuerological coil (3T Advanced Neurological (Brain) Array MR Coil)MR Diagnostic Imaging will be performed on both TBI subjects and Non TBI subjects | Device | Experimental: Diagnostic Non mTBI, Experimental: Diagnostic mTBI |
Primary outcome
mTBI Progression Indicated by Clinical Neurological Characteristics, MRI Images, and Quantitative MRI Data From Novel Software
Time frame: Per-patient 1 to 3 months, until dataset completion 1 yr
To determine associations between clinical neurological data, MR images, quantitative data from novel software post-processing (sponsor developed software including volumetry, Resting State [RS] functional magnetic resonance imaging [fMRI], kurtosis).
2 secondary outcomes
Subject Demographics
Time frame: Per-patient 1 to 3 months, until dataset completion 1 yr
Operator Set MRI Parameters
Time frame: Per-patient 1 to 3 months, until dataset completion 1 yr
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Teena Shetty, MD principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MRI in people with Mild Traumatic Brain Injury and Traumatic Brain Injury, run by GE Healthcare 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 8 inclusion and 17 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: stopped early, as of the sponsor's last update on 21 Jul 2017. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 21 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
mTBI Progression Indicated by Clinical Neurological Characteristics, MRI Images, and Quantitative MRI Data From Novel Software (time frame: Per-patient 1 to 3 months, until dataset completion 1 yr). 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 21 Jul 2017.