Brain TraumaNCT00760903
Magnetic Resonance (MR) Spectroscopy and Diffusion Tensor Imaging in Determining Brain Injury and Subsequent Clinical Outcome in Patients of Moderate Brain Trauma
An observational study of Brain Trauma, run by University of Michigan at 1 site in United States.
Trial summary
The purpose of this study is to use magnetic resonance spectroscopy (MRS) and diffusion tensor imaging (DTI) to assess for traumatic brain injury and determine if there is any correlation of these findings to clinical outcome. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Brain Trauma
- What is being tested?
- Conventional MRI of the brain, MR spectroscopy (MRS) and MR Diffusion Tensor Imaging (DTI)
- Type of treatment
- Injection or infusion
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2003to Sep 2009
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Have had a clinically ordered CT exam performed within 24 hours of admission to the hospital. We will be enrolling 5 different groups of subjects into this study. These groups include patients18 years of age or older with moderate to severe head trauma. Children under 18 years of age with moderate to severe head trauma. A group of patients of any age who have already undergone conventional MRI of the brain and a group of volunteers who are part of another research study.
Who may be able to join
- Patients of acute moderate brain trauma
Who cannot join
- Patients who are medically unstable or have CT findings that may interfere with the study such as:
- a large hemorrhage or edema
- encephalomalacia
- prior neurosurgeries
- hardware placed in the head or neck
- prior head trauma
- history of neurological conditions
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to use magnetic resonance spectroscopy (MRS) and diffusion tensor imaging (DTI) to assess for traumatic brain injury and determine if there is any correlation of these findings to clinical outcome. MR spectroscopy using 2D-CSI (a multi voxel technique) of the corpus callosum, basal ganglia, lobar white matter and brainstem may reveal areas of injury and quantification of the metabolites from these areas may be used to correlate with imaging findings and clinical evaluation. White matter disruption in these areas is commonly seen after TBI, caused by diffuse axonal injury. It has been implicated in the long term outcomes in these patients, but has been difficult to assess by standard radiologic studies.
By the use of DTI it may be possible to demonstrate damaged white matter tracts which could be helpful in the evaluation of traumatic brain injury. Most TBI subjects have injuries that involved torque to the brain. This results in a shearing injury to the long white matter tracts, which has been hypothesized to be related to cognitive outcome.
Read more
Also, to demonstrate that MRS and DTI prove valuable in predicting outcome in patients of moderate brain trauma by conducting progressive studies acutely (within 24 hours) and long term (4-6 weeks). Most patients will most likely be followed clinically for over a year, and, if clinical indicated, farther scanning can be done at a later date.
By comparing fraction anisotropy, ADC values, and metabolic ratios by the use of DTI and MRS in the adult and pediatric populations, may help to assess differences in recovery.
Lastly, a comparison between the two groups in changes in brain metabolism and/or white matter tract disruption/re-connection after TBI with and/or without links to outcome can be done.
Read the detailed description
The purpose of this study is to determine if MRI imaging can accurately detect the clinical outcome (extent of recovery) of patients who have moderate to severe brain injury. This study may show that MRI can provide a clearer picture on the extent of the brain injury and help medical physicians decide how to best treat these patients with a more accurate idea of the brain function of the recovering patient.
- Conditions
- Brain Trauma
- Being tested
- Conventional MRI of the brain, MR spectroscopy (MRS), MR Diffusion Tensor Imaging (DTI)
- Keywords
- Moderate brain trauma
- 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.
Conventional MRI of the brainOther
MR spectroscopy (MRS)Other
MR Diffusion Tensor Imaging (DTI)Other
| Study group | Role | What they receive |
|---|---|---|
| > 18 years moderate head trauma | Group I: (Pilot group): 5-10 patients > 18 years old, gender and race indifferent with moderate head trauma. Receives: Other: Conventional MRI of the brain; Other: MR spectroscopy (MRS); Other: MR Diffusion Tensor Imaging (DTI) | |
| > 18, gender and race indifferent | Group II: 30 patients > 18 years old, gender, and race indifferent with moderate head trauma Receives: Other: Conventional MRI of the brain; Other: MR spectroscopy (MRS); Other: MR Diffusion Tensor Imaging (DTI) | |
| Pediatric | Group III: 30 patients < 18 years old, gender and race indifferent with moderate head trauma (pediatric patient group) Receives: Other: Conventional MRI of the brain; Other: MR spectroscopy (MRS); Other: MR Diffusion Tensor Imaging (DTI) | |
| Pre-evaluated | Group IV: 10-20 patients age, gender and race indifferent with moderate head trauma that have been examined with conventional MRI of the brain, MRS and DTI as clinically requested. The images of these patients will be evaluated retrospectively for data- point collection. Receives: Other: Conventional MRI of the brain; Other: MR spectroscopy (MRS); Other: MR Diffusion Tensor Imaging (DTI) | |
| Control Group | Group V (control group): 20 volunteers without prior history of traumatic brain injury or neurological problems. Receives: Other: Conventional MRI of the brain; Other: MR spectroscopy (MRS); Other: MR Diffusion Tensor Imaging (DTI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if MRI imaging can accurately detect the clinical outcome (extent of recovery) of patients who have moderate to severe brain injury.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2008 (estimated)
- Study startJun 2003
- Primary completionSep 2008
- Study completionSep 2009
Why it stopped: Study was not started due to PI concentrating on other studies
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TraumaStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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
- Case-control
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pia C Maly Sundgren, MD, PhD, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00760903
- Sponsor's protocol ID
- 2003-0053
- Status last verified
- Jan 2017
- First submitted
- 24 Sep 2008
- Last updated
- 6 Jan 2017
- 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 6 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Resonance (MR) Spectroscopy and Diffusion Tensor Imaging in Determining Brain Injury and Subsequent Clinical Outcome in Patients of Moderate Brain Trauma
- ClinicalTrials.gov ID
- NCT00760903
- Acronym / sponsor ID
- 2003-0053
- Conditions
- Brain Trauma
- Keywords
- Moderate brain trauma
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Study was not started due to PI concentrating on other studies
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Jun 2003
- Primary completion
- Sep 2008 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 26 Sep 2008 (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 purpose of this study is to use magnetic resonance spectroscopy (MRS) and diffusion tensor imaging (DTI) to assess for traumatic brain injury and determine if there is any correlation of these findings to clinical outcome. MR spectroscopy using 2D-CSI (a multi voxel technique) of the corpus callosum, basal ganglia, lobar white matter and brainstem may reveal areas of injury and quantification of the metabolites from these areas may be used to correlate with imaging findings and clinical evaluation. White matter disruption in these areas is commonly seen after TBI, caused by diffuse axonal injury. It has been implicated in the long term outcomes in these patients, but has been difficult to assess by standard radiologic studies.
By the use of DTI it may be possible to demonstrate damaged white matter tracts which could be helpful in the evaluation of traumatic brain injury. Most TBI subjects have injuries that involved torque to the brain. This results in a shearing injury to the long white matter tracts, which has been hypothesized to be related to cognitive outcome.
Also, to demonstrate that MRS and DTI prove valuable in predicting outcome in patients of moderate brain trauma by conducting progressive studies acutely (within 24 hours) and long term (4-6 weeks). Most patients will most likely be followed clinically for over a year, and, if clinical indicated, farther scanning can be done at a later date.
By comparing fraction anisotropy, ADC values, and metabolic ratios by the use of DTI and MRS in the adult and pediatric populations, may help to assess differences in recovery.
Lastly, a comparison between the two groups in changes in brain metabolism and/or white matter tract disruption/re-connection after TBI with and/or without links to outcome can be done.
Detailed description
The purpose of this study is to determine if MRI imaging can accurately detect the clinical outcome (extent of recovery) of patients who have moderate to severe brain injury. This study may show that MRI can provide a clearer picture on the extent of the brain injury and help medical physicians decide how to best treat these patients with a more accurate idea of the brain function of the recovering patient.
Study design
- Observational model
- Case-control
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| > 18 years moderate head trauma | – | Other: Conventional MRI of the brain, Other: MR spectroscopy (MRS), Other: MR Diffusion Tensor Imaging (DTI)Group I: (Pilot group): 5-10 patients > 18 years old, gender and race indifferent with moderate head trauma. |
| > 18, gender and race indifferent | – | Other: Conventional MRI of the brain, Other: MR spectroscopy (MRS), Other: MR Diffusion Tensor Imaging (DTI)Group II: 30 patients > 18 years old, gender, and race indifferent with moderate head trauma |
| Pediatric | – | Other: Conventional MRI of the brain, Other: MR spectroscopy (MRS), Other: MR Diffusion Tensor Imaging (DTI)Group III: 30 patients < 18 years old, gender and race indifferent with moderate head trauma (pediatric patient group) |
| Pre-evaluated | – | Other: Conventional MRI of the brain, Other: MR spectroscopy (MRS), Other: MR Diffusion Tensor Imaging (DTI)Group IV: 10-20 patients age, gender and race indifferent with moderate head trauma that have been examined with conventional MRI of the brain, MRS and DTI as clinically requested. The images of these patients will be evaluated retrospectively for data- point collection. |
| Control Group | – | Other: Conventional MRI of the brain, Other: MR spectroscopy (MRS), Other: MR Diffusion Tensor Imaging (DTI)Group V (control group): 20 volunteers without prior history of traumatic brain injury or neurological problems. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Have had a clinically ordered CT exam performed within 24 hours of admission to the hospital. We will be enrolling 5 different groups of subjects into this study. These groups include patients18 years of age or older with moderate to severe head trauma. Children under 18 years of age with moderate to severe head trauma. A group of patients of any age who have already undergone conventional MRI of the brain and a group of volunteers who are part of another research study.
Key inclusion criteria (1 listed)
- Patients of acute moderate brain trauma
Key exclusion criteria (7 listed)
- Patients who are medically unstable or have CT findings that may interfere with the study such as:
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 |
|---|---|---|
| Conventional MRI of the brain | Other | > 18 years moderate head trauma, > 18, gender and race indifferent, Control Group, Pediatric, Pre-evaluated |
| MR spectroscopy (MRS) | Other | > 18 years moderate head trauma, > 18, gender and race indifferent, Control Group, Pediatric, Pre-evaluated |
| MR Diffusion Tensor Imaging (DTI) | Other | > 18 years moderate head trauma, > 18, gender and race indifferent, Control Group, Pediatric, Pre-evaluated |
Primary outcome
To determine if MRI imaging can accurately detect the clinical outcome (extent of recovery) of patients who have moderate to severe brain injury.
Time frame: 1 year
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 6 Jan 2017.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Brain Trauma, run by University of Michigan 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 1 inclusion and 7 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 6 Jan 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. 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?
To determine if MRI imaging can accurately detect the clinical outcome (extent of recovery) of patients who have moderate to severe brain injury. (time frame: 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 6 Jan 2017.