Traumatic Brain InjuryImaging of TBINCT01196299
Imaging of Traumatic Brain Injury
An observational study of Traumatic Brain Injury, run by University of Maryland, Baltimore at 1 site in United States.
Trial summary
This project aims to study the prognostic ability of various MRI imaging markers in the evaluation of TBI patients. Cognitive, social, and occupational recovery will be measured at each time point, and compared to MRI findings. Healthy volunteers will serve as a comparison to the TBI patients. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Mar 2010to 5 Sep 2015
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients admitted with head trauma ranging from mild to severe.
Who may be able to join
- Age 18 or older
- Evidence of external head injury or facial trauma, or mechanism of injury consistent with brain trauma, including loss of consciousness or altered mental status.
- Residence within 90 minutes driving time of University of Maryland Medical Center, and willingness to attend follow-up appointments.
Who cannot join
- History of white matter disease or neurodegenerative disorders including Multiple Sclerosis, Huntington's Disease, Alzheimer's Disease, or Pick's Disease.
- History of Stroke
- History of treatment or diagnosis of psychiatric conditions: Major Depressive Disorder (MDD), Bipolar Disorder (BPD), Schizophrenia, or Dementia of any type.
- History of Brain Tumor
- Status post trauma due to asphyxiation
- Preexisting contraindications for Magnetic Resonance Imaging (MRI)
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- Active Duty Military Status
- Police custody or prisoner status
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland Medical Center
Baltimore, Maryland, 21201
About this study
Official title: Prognostic Value of MR Imaging Markers in the Assessment of Traumatic Brain Injury Patients
This project aims to study the prognostic ability of various MRI imaging markers in the evaluation of TBI patients. Cognitive, social, and occupational recovery will be measured at each time point, and compared to MRI findings. Healthy volunteers will serve as a comparison to the TBI patients.
It is hypothesized that novel MRI markers of metabolism, hemodynamics, functional connectivity, and tissue microstructure will be related to the clinical status of the patient, as well as their social and occupational outcomes.
Read the detailed description
The goal of this study is to identify advanced magnetic resonance imaging markers that can serve as a prognostic marker in the evaluation and management of traumatic brain injury patients.
Magnetic resonance imaging and cognitive testing (when possible) will be performed in the acute (within 10 days following injury), and recovery stages (about 1 month, about 6 months,and about 18 months). The relationship between the advanced magnetic resonance imaging markers and the clinical condition of the patient will be evaluated at each time point to determine which combination of imaging markers best describe the current clinical status of the patient and which markers best predict a patient's outcome status.
- Conditions
- Traumatic Brain Injury
- Keywords
- diffusion tensor imaging, magnetic resonance spectroscopy, traumatic brain injury, Metabolite changes, Cerebral perfusion, Hemorrhagic burden
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Severe Traumatic Brain Injury Group | The severe traumatic brain injury group are patients admitted to the study with an admission GCS between 3 and 8. | |
| Moderate Head Injury Group | The moderate head injury group are patients admitted to the study with an admission GCS from 9 to 12. | |
| Mild Head Injury Group | The mild head injury group are patients admitted to the study with an admission GCS from 13 to 15. | |
| Healthy Volunteer Group | Healthy volunteers will be selected to match the age distribution of the TBI groups. They must be absent of any abnormal radiological findings. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of advanced MR imaging markers
Systematically study the imaging markers obtained from novel MRI techniques (diffusion tensor imaging (DTI), susceptibility-weighted imaging (SWI), MR spectroscopy, resting state MRI, and arterial spin labeling) and assess the markers for sensitivity.
Measured: 18 months post-injury
Secondary outcomes (4)
level of cognitive function
Measured: 18 months post-injury
extent of disability
Measured: 18 months post-injury
level of orientation
Measured: 18 months post-injury
level of functional independence
Measured: 18 months post-injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2010 (estimated)
- Study start21 Mar 2010
- Primary completion17 Apr 2015
- Study completion5 Sep 2015
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 University of Maryland, BaltimoreThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rao P Gullapalli, University of Maryland, Baltimore
- Investigators
- Rao P Gullapalli, PhD, Principal investigator, University of Maryland Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01196299
- Sponsor's protocol ID
- HP-00040713
- Other IDs
- W81XWH-08-1-0725
- Acronym
- Imaging of TBI
- Status last verified
- Jul 2022
- First submitted
- 3 Sep 2010
- Last updated
- 21 Jul 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of MR Imaging Markers in the Assessment of Traumatic Brain Injury Patients
- ClinicalTrials.gov ID
- NCT01196299
- Acronym / sponsor ID
- Imaging of TBI / HP-00040713
- Conditions
- Traumatic Brain Injury
- Keywords
- diffusion tensor imaging, magnetic resonance spectroscopy, traumatic brain injury, Metabolite changes, Cerebral perfusion, Hemorrhagic burden
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 21 Mar 2010 (actual)
- Primary completion
- 17 Apr 2015 (actual)
- Study completion
- 5 Sep 2015 (actual)
- First posted
- 8 Sep 2010 (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.
This project aims to study the prognostic ability of various MRI imaging markers in the evaluation of TBI patients. Cognitive, social, and occupational recovery will be measured at each time point, and compared to MRI findings. Healthy volunteers will serve as a comparison to the TBI patients.
It is hypothesized that novel MRI markers of metabolism, hemodynamics, functional connectivity, and tissue microstructure will be related to the clinical status of the patient, as well as their social and occupational outcomes.
Detailed description
The goal of this study is to identify advanced magnetic resonance imaging markers that can serve as a prognostic marker in the evaluation and management of traumatic brain injury patients.
Magnetic resonance imaging and cognitive testing (when possible) will be performed in the acute (within 10 days following injury), and recovery stages (about 1 month, about 6 months,and about 18 months). The relationship between the advanced magnetic resonance imaging markers and the clinical condition of the patient will be evaluated at each time point to determine which combination of imaging markers best describe the current clinical status of the patient and which markers best predict a patient's outcome status.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Severe Traumatic Brain Injury Group | – | –The severe traumatic brain injury group are patients admitted to the study with an admission GCS between 3 and 8. |
| Moderate Head Injury Group | – | –The moderate head injury group are patients admitted to the study with an admission GCS from 9 to 12. |
| Mild Head Injury Group | – | –The mild head injury group are patients admitted to the study with an admission GCS from 13 to 15. |
| Healthy Volunteer Group | – | –Healthy volunteers will be selected to match the age distribution of the TBI groups. They must be absent of any abnormal radiological findings. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted with head trauma ranging from mild to severe.
Key inclusion criteria (3 listed)
- Age 18 or older
- Evidence of external head injury or facial trauma, or mechanism of injury consistent with brain trauma, including loss of consciousness or altered mental status.
- Residence within 90 minutes driving time of University of Maryland Medical Center, and willingness to attend follow-up appointments.
Key exclusion criteria (9 listed)
- History of white matter disease or neurodegenerative disorders including Multiple Sclerosis, Huntington's Disease, Alzheimer's Disease, or Pick's Disease.
- History of Stroke
- History of treatment or diagnosis of psychiatric conditions: Major Depressive Disorder (MDD), Bipolar Disorder (BPD), Schizophrenia, or Dementia of any type.
- History of Brain Tumor
- Status post trauma due to asphyxiation
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
Identification of advanced MR imaging markers
Time frame: 18 months post-injury
Systematically study the imaging markers obtained from novel MRI techniques (diffusion tensor imaging (DTI), susceptibility-weighted imaging (SWI), MR spectroscopy, resting state MRI, and arterial spin labeling) and assess the markers for sensitivity.
4 secondary outcomes
level of cognitive function
Time frame: 18 months post-injury
extent of disability
Time frame: 18 months post-injury
level of orientation
Time frame: 18 months post-injury
level of functional independence
Time frame: 18 months post-injury
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
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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.
Rao P Gullapalli, PhD principal investigator
University of Maryland Medical School
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 Traumatic Brain Injury, run by University of Maryland, Baltimore 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 3 inclusion and 9 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 21 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Identification of advanced MR imaging markers (time frame: 18 months post-injury). 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 2022.