ConcussionmTBI-phase2NCT02556177

Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2

A study testing MRI in people with Concussion and Traumatic Brain Injury, run by GE Healthcare at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This is an open-label, non-randomized, prospective, multi-site, parallel group (segment), hypothesis-generating study designed to collect data that will aid in future scientific and engineering exploration of correlations between clinical neuropsychological assessments and GE Research Pack II advanced MR imaging in… Read more about this study

Who is it for?: Ages 15 to 50 yearsHealthy volunteers can take part
Conditions the study is for: Concussion, Traumatic Brain Injury
What is being tested?: MRI
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 477 participants
Where: 7 sitesUnited States
Study dates: Nov 2015to 31 Jan 2018
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

Subjects included as mTBI patients (Segment 1) will:
Be aged ≥15 and ≤50 years old at the time of enrollment;
Be diagnosed with mTBI according to the standard diagnostic procedures at the investigational site in a timeframe that meets enrollment criteria for enrollment within 72 hours (Visit 1) or 7±2 days (Visit 3) from injury.
Be capable of sufficiently clear communication and language fluency to allow the subject to provide written informed consent, or assent with parental or guardian consent for minors, and to complete study assessments (as per Section 6.3 - Protection of Vulnerable Subjects) for participation in all parts of the study.
Subjects included as non-mTBI controls (Segment 2) will:
Be aged ≥15 and ≤50 years old at the time of enrollment;
Are of similar characteristics as the mTBI population in terms of gender, age, handedness, educational level, and scanner criteria (as per Section 6.1.1 Enrollment of non-mTBI controls)
Be capable of sufficiently clear communication and language fluency to allow the subject to provide written informed consent, or assent with parental or guardian consent for minors, and to complete study assessments (as per Section 6.3 - Protection of Vulnerable Subjects), for participation in all parts of the study.

Who cannot join

Subjects will be excluded that have: mTBI
Loss of consciousness (LOC) ≥5 minutes;
Posttraumatic amnesia lasting ≥24 hr following mTBI;
Current or prior (within past 10 years) moderate to severe TBI
Diagnosis of mTBI within the past 6 months;
Epilepsy with recurring seizures in past 10 years;

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Drug abuse (except marijuana) in past 10 years based on DAST-10 screening;
Alcohol abuse based on AUDIT-C screening;
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 C - Screening Axis I/II Disorders):
History of brain mass, neurosurgery, stroke, white matter disease, and/or dementia;
Known cognitive dysfunction or structural brain disease/malformation;
Structural brain injury on prior neuroimaging findings;
Been prescribed antipsychotic/antiepileptic medications;
Unable (such as due to urgent medical care needs) or unwilling to complete study procedures accurately or have any conflict of interest that could affect study results, in the opinion of the investigator;
Contraindications to MRI scanning, including:
Current or suspected pregnancy, per site practice;
Other conditions that may constitute a hazard to the subject during study participation, per investigator;
Inability to comply with any part of the site's MR safety policy.
Subjects will be excluded that have:- non-TBI (controls)
Diagnosis of mTBI within the past 6 months;
Prior (within past 10 years) moderate to severe TBI (GCS <13);
Epilepsy with recurring seizures in past 10 years;
Drug abuse (except marijuana) in past 10 years based on DAST-10 screening;
Alcohol abuse based on AUDIT-C screening;
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 C - Screening Axis I/II Disorders):
History of brain mass, neurosurgery, stroke, white matter disease, and/or dementia;
Known cognitive dysfunction or structural brain disease/malformation;
Structural brain injury on prior neuroimaging findings;
Been prescribed antipsychotic/antiepileptic medications;
Unable (such as due to urgent medical care needs) or unwilling to complete study procedures accurately or have any conflict of interest that could affect study results, in the opinion of the investigator;

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

Houston Methodist Neurological Institute
Houston, Texas, 77030
Universtiy of Miami Health System
Miami, Florida, 33136
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Hospital for Special Surgery
New York, New York, 10021
University of Pittsburgh Medical College
Pittsburgh, Pennsylvania, 15203
University of California-San Diego
San Diego, California, 92161
University of California San Francisco
San Francisco, California, 94121

Other trials in United States

About this study

Read the detailed description

This data-driven study is being conducted for hypothesis generation in population of mild traumatic brain injury (mTBI) patients using advanced applications for magnetic resonance imaging (MRI) developed by the Sponsor, GE Healthcare (GEHC), and corresponding clinical neuropsychological assessments. This data is intended for future use in development of specialized MR acquisition, reconstruction, and processing software intended to identify mTBI biomarkers.

Conditions: Concussion, Traumatic Brain Injury
Being tested: MRI
Keywords: TBI, MR, mTBI, NFL, MRI
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.

MRIProcedure or surgery
MRI scanning

Study groups in NCT02556177
Study group	Role	What they receive
mTBI patient group (Segment 1)	Active comparator	1.5T or 3.0T MRI brain scanning with research sequences at 3 to 4 intervals in the acute period, with psychological cognitive evaluations at each MR visit Patients in the acute period following recent diagnosis of mild traumatic brain injury (mTBI) Receives: Procedure: MRI
non-TBI patients (Segment 2)	Active comparator	Control subjects with no recent mild traumatic brain injury. 1.5T or 3.0T MRI brain scanning with research sequences at 3 to 4 intervals in the acute period, with psychological cognitive evaluations at each MR visit Receives: Procedure: MRI

What is being measured

The primary outcome is the main question the study is designed to answer.

MRI Image Data Sets
MRI image data sets collected from subjects who completed the study.
Measured: Per patient scanning over 3 months
Neuropsychological Assessments
Neuropsychological assessments collected from subjects who completed the study.
Measured: Per patient scanning over 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Nov 201531 Jan 2018

First posted22 Sep 2015 (estimated)
Study startNov 2015
Primary completion31 Jan 2018
Study completion31 Jan 2018

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.
Publications (2)Papers the sponsor has linked to this study.
Other trials for ConcussionStudies 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: Parallel groups
Masking: None (open label)
Enrolment: 477 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02556177
Sponsor's protocol ID: 114-2015-GES-0017
Acronym: mTBI-phase2
Status last verified: Sep 2019
First submitted: 7 Aug 2015
Last updated: 10 Sep 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Gangolli M, Perkins NJ, Marinelli L, Basser PJ, Avram AV. Longitudinal MAP-MRI-based Assessment of Tissue Microstructural Alterations in Acute mTBI. medRxiv [Preprint]. 2026 Apr 9:2026.04.06.26350074. doi: 10.64898/2026.04.06.26350074.
PubMed 42388887
Tanwar M, Miller E, Tsiouris AJ, Nguyen J, Agarwal V, Marinelli L, Erdemir GA, Shetty T. White Matter Hyperintensities on High-Resolution 3-T MRI: Frequency in Mild Traumatic Brain Injury and Associations With Clinical Markers-A Prospective Controlled Multicenter Study. AJR Am J Roentgenol. 2025 May;224(5):e2432274. doi: 10.2214/AJR.24.32274. Epub 2025 Feb 19.
PubMed 39969142

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
Active, not recruiting
Pilot TMS in Mild TBI
Persistent Post Concussive Headache, Mild Traumatic Brain Injury
Recruiting
Non-invasive Stimulation of the Glymphatic System for Slowing Cognitive Decline
Mild Traumatic Brain Injury, Post Concussion Syndrome
Enrolling by invitation
Improving In-hospital and Post-discharge Patient Education for Mild Traumatic Brain Injury
Concussion, Mild, Traumatic Brain Injury

All Concussion trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Advanced MRI Applications for Mild Traumatic Brain Injury-Phase 2
ClinicalTrials.gov ID: NCT02556177
Acronym / sponsor ID: mTBI-phase2 / 114-2015-GES-0017
Conditions: Concussion, Traumatic Brain Injury
Keywords: TBI, MR, mTBI, NFL, MRI
Study type: Interventional
Recruitment status: Completed
Enrolment: 477 participants (actual)
Lead sponsor: GE HealthcareIndustry (pharma, biotech, devices)
Collaborators: ICON plc
Study start: Nov 2015
Primary completion: 31 Jan 2018 (actual)
Study completion: 31 Jan 2018 (actual)
First posted: 22 Sep 2015 (estimated)
Results: Posted 10 Sep 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
mTBI patient group (Segment 1)	Active comparator	Procedure: MRI1.5T or 3.0T MRI brain scanning with research sequences at 3 to 4 intervals in the acute period, with psychological cognitive evaluations at each MR visit Patients in the acute period following recent diagnosis of mild traumatic brain injury (mTBI)
non-TBI patients (Segment 2)	Active comparator	Procedure: MRIControl subjects with no recent mild traumatic brain injury. 1.5T or 3.0T MRI brain scanning with research sequences at 3 to 4 intervals in the acute period, with psychological cognitive evaluations at each MR visit

Who may qualify

Ages: 15 to 50 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (8 listed)

Be aged ≥15 and ≤50 years old at the time of enrollment;
Be diagnosed with mTBI according to the standard diagnostic procedures at the investigational site in a timeframe that meets enrollment criteria for enrollment within 72 hours (Visit 1) or 7±2 days (Visit 3) from injury.
Be capable of sufficiently clear communication and language fluency to allow the subject to provide written informed consent, or assent with parental or guardian consent for minors, and to complete study assessments (as per Section 6.3 - Protection of Vulnerable Subjects) for participation in all parts of the study.
Be aged ≥15 and ≤50 years old at the time of enrollment;
Are of similar characteristics as the mTBI population in terms of gender, age, handedness, educational level, and scanner criteria (as per Section 6.1.1 Enrollment of non-mTBI controls)

Key exclusion criteria (30 listed)

Subjects will be excluded that have: mTBI
Loss of consciousness (LOC) ≥5 minutes;
Posttraumatic amnesia lasting ≥24 hr following mTBI;
Current or prior (within past 10 years) moderate to severe TBI
Diagnosis of mTBI within the past 6 months;

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
MRIMRI scanning	Procedure or surgery	mTBI patient group (Segment 1), non-TBI patients (Segment 2)

Primary outcome

MRI Image Data Sets
Time frame: Per patient scanning over 3 months
MRI image data sets collected from subjects who completed the study.
Neuropsychological Assessments
Time frame: Per patient scanning over 3 months
Neuropsychological assessments collected from subjects who completed the study.

Results and safety

Results posted to the registry on 10 Sep 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
mTBI Patient Group (Segment 1)	325	42
Non-TBI Patients (Segment 2)	152	91

Primary outcome: MRI Image Data Sets

Time frame: Per patient scanning over 3 months. Number. Unit: Images collected

Measure	mTBI Patient Group (Segment 1) n = 325	Non-TBI Patients (Segment 2) n = 152
Study Visit 1 images collected	79	150
Study Visit 2 images collected	290	111
Study Visit 3 images collected	240	105
Study Visit 4 images collected	218	118
Total number of images collected	827	484

Primary outcome: Neuropsychological Assessments

Time frame: Per patient scanning over 3 months. Number. Unit: Neuropsychological assessments

Measure	mTBI Patient Group (Segment 1) n = 325	Non-TBI Patients (Segment 2) n = 152
Visit 1 Neuropsychological assessments	84	152
Visit 2 Neuropsychological assessments	303	114
Visit 3 Neuropsychological assessments	244	107
Visit 4Neuropsychological assessments	222	119
Total number of Neuropsychological assessments	853	492

Adverse events

Time frame: Each visit lasted approximately 90 minutes.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
mTBI Patient Group (Segment 1)	0 of 325 (0%)	22 of 325 (6.8%)	0 of 325
Non-TBI Patients (Segment 2)	0 of 152 (0%)	1 of 152 (0.7%)	0 of 152

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42388887Gangolli M, Perkins NJ, Marinelli L, Basser PJ, Avram AV. Longitudinal MAP-MRI-based Assessment of Tissue Microstructural Alterations in Acute mTBI. medRxiv [Preprint]. 2026 Apr 9:2026.04.06.26350074. doi: 10.64898/2026.04.06.26350074.
Derived from this study: PubMed 39969142Tanwar M, Miller E, Tsiouris AJ, Nguyen J, Agarwal V, Marinelli L, Erdemir GA, Shetty T. White Matter Hyperintensities on High-Resolution 3-T MRI: Frequency in Mild Traumatic Brain Injury and Associations With Clinical Markers-A Prospective Controlled Multicenter Study. AJR Am J Roentgenol. 2025 May;224(5):e2432274. doi: 10.2214/AJR.24.32274. Epub 2025 Feb 19.

Related trials for Concussion

Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
Mild Traumatic Brain Injury
Recruiting
Evaluation of Cognitive Behavioral Therapy for Insomnia (CBT-I) in Individuals With Mild Traumatic Brain Injury (mTBI)
Sleep Architecture, Mild Traumatic Brain Injury
Active, not recruiting
Pilot TMS in Mild TBI
Persistent Post Concussive Headache, Mild Traumatic Brain Injury
Recruiting
Non-invasive Stimulation of the Glymphatic System for Slowing Cognitive Decline
Mild Traumatic Brain Injury, Post Concussion Syndrome
Enrolling by invitation
Improving In-hospital and Post-discharge Patient Education for Mild Traumatic Brain Injury
Concussion, Mild, Traumatic Brain Injury

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.

Victor Miranda, MD study director

GE Healthcare

7 sites 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 Concussion and Traumatic Brain Injury, run by GE Healthcare at 7 sites 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 30 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: finished, as of the sponsor's last update on 10 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites 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?

Yes. Results are posted in the registry (first posted 10 Sep 2019). 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?

MRI Image Data Sets (time frame: Per patient scanning over 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02556177, which also lists 2 linked publications.

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 Sep 2019.