Traumatic Brain InjurySANICNCT01075035
Multimodal Neurodiagnostic Imaging of Traumatic Brain Injury and Post-Traumatic Stress Disorder
An observational study of Traumatic Brain Injury and Post-Traumatic Stress Disorder, run by St. Louis University at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the brains of persons with and without traumatic brain injury differ in a meaningful way when advanced technology images of the brain are taken using three newer technologies that visualize the brain using a combination of external/internal magnetic fields and… 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, Post-Traumatic Stress Disorder
- How many people
- 224 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Aug 2014
- 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: 50-60 Normal Healthy Controls 50-60 Civilian TBI 50-60 Military TBI
Who may be able to join
- At least 18 years of age and non-active duty
- Either:
- Normal (no history of head injury) -OR-
- TBI (injury since Jan. 1, 2002)
Who cannot join
- Incapable of informed consent or absence of legally authorized representative.
- Incarcerated (or subject to court supervision).
- Known allergy to protocol contrast/imaging agent (or pregnant and unable to receive agent)
- MRI incompatible (i.e. implant, metal, > 300 lbs, severe claustrophobia)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evidence Based Multimodal Neurodiagnostic Imaging of Traumatic Brain Injury and Post-Traumatic Stress Disorder at the Saint Louis University Advanced Neurosurgical Innovation Center (SANIC)
The purpose of this study is to determine whether the brains of persons with and without traumatic brain injury differ in a meaningful way when advanced technology images of the brain are taken using three newer technologies that visualize the brain using a combination of external/internal magnetic fields and radioactive tracers (molecules that emit detectable particles). The hope is that the results of this study will validate tools (help prove that diagnostic tools actually detect disease) for the diagnosis and treatment of traumatic brain injuries (TBI).
Read the detailed description
'Normal' appearing brain is often not normal when imaged with advanced neuroimaging techniques. It has been advocated that a battery of neurological assessments (including MEG) be developed to assess mild traumatic brain injury (TBI) and studies have shown that somatosensory evoked fields in severe TBI can serve as a measure of cortical function in comatosed TBI patients. Functional neuroimaging techniques such as PET and fMRI may reveal abnormalities in areas considered 'normal' on traditional MRI. Most significantly, advanced functional neuroimaging may enable customized neurorehabilitation planning with more efficient use of resources.
The study aim is to compare healthy brains, civilian TBI brains, and combat-related TBI to identify correlations between abnormal imaging parameters with neurorehabilitation potential utilizing advanced neurological imaging.
The study hypothesis states Severity of Traumatic Brain Injury (TBI) and Post-traumatic Stress Disorders (PTSD) can be detected and quantified using a multimodal battery of neurodiagnostic imaging techniques (MEG, PET/CT, 3 Tesla-MRI w/ DTI and fMRI) and rehabilitation potential can be predicted in the post acute phase.
- Keywords
- Traumatic Brain Injury, TBI, Military, Imaging, MEG, PET/CT, MRI, fMRI, DTI, SANIC, veteran
- Medical subject headings
- Brain Injuries, Traumatic, Stress Disorders, Post-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 |
|---|---|---|
| Normal Healthy Controls | Individuals with no history of Traumatic Brain Injury. | |
| Civilian TBI | Civilians who have had a Traumatic Brain Injury | |
| Military TBI | Combat military veterans who have had a Traumatic Brain Injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurocognitive Testing (PET/CT, MEG, fMRI w/ DTI)results
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2010 (estimated)
- Study startAug 2008
- Primary completionAug 2014
- Study completionAug 2014
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.
- 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
- Time perspective
- Prospective
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense
- Responsible party
- Sponsor
- Investigators
- Richard Bucholz, M.D., Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01075035
- Sponsor's protocol ID
- PT075832-R01
- Other IDs
- A-15194, IRB # 15919
- Acronym
- SANIC
- Status last verified
- Apr 2014
- First submitted
- 23 Feb 2010
- Last updated
- 11 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence Based Multimodal Neurodiagnostic Imaging of Traumatic Brain Injury and Post-Traumatic Stress Disorder at the Saint Louis University Advanced Neurosurgical Innovation Center (SANIC)
- ClinicalTrials.gov ID
- NCT01075035
- Acronym / sponsor ID
- SANIC / PT075832-R01
- Keywords
- Traumatic Brain Injury, TBI, Military, Imaging, MEG, PET/CT, MRI, fMRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Collaborators
- United States Department of Defense
- Study start
- Aug 2008
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 24 Feb 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.
The purpose of this study is to determine whether the brains of persons with and without traumatic brain injury differ in a meaningful way when advanced technology images of the brain are taken using three newer technologies that visualize the brain using a combination of external/internal magnetic fields and radioactive tracers (molecules that emit detectable particles). The hope is that the results of this study will validate tools (help prove that diagnostic tools actually detect disease) for the diagnosis and treatment of traumatic brain injuries (TBI).
Detailed description
'Normal' appearing brain is often not normal when imaged with advanced neuroimaging techniques. It has been advocated that a battery of neurological assessments (including MEG) be developed to assess mild traumatic brain injury (TBI) and studies have shown that somatosensory evoked fields in severe TBI can serve as a measure of cortical function in comatosed TBI patients. Functional neuroimaging techniques such as PET and fMRI may reveal abnormalities in areas considered 'normal' on traditional MRI. Most significantly, advanced functional neuroimaging may enable customized neurorehabilitation planning with more efficient use of resources.
The study aim is to compare healthy brains, civilian TBI brains, and combat-related TBI to identify correlations between abnormal imaging parameters with neurorehabilitation potential utilizing advanced neurological imaging.
The study hypothesis states Severity of Traumatic Brain Injury (TBI) and Post-traumatic Stress Disorders (PTSD) can be detected and quantified using a multimodal battery of neurodiagnostic imaging techniques (MEG, PET/CT, 3 Tesla-MRI w/ DTI and fMRI) and rehabilitation potential can be predicted in the post acute phase.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Normal Healthy Controls | – | –Individuals with no history of Traumatic Brain Injury. |
| Civilian TBI | – | –Civilians who have had a Traumatic Brain Injury |
| Military TBI | – | –Combat military veterans who have had a Traumatic Brain Injury |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 50-60 Normal Healthy Controls 50-60 Civilian TBI 50-60 Military TBI
Key inclusion criteria (4 listed)
- At least 18 years of age and non-active duty
- Either:
Key exclusion criteria (4 listed)
- Incapable of informed consent or absence of legally authorized representative.
- Incarcerated (or subject to court supervision).
- Known allergy to protocol contrast/imaging agent (or pregnant and unable to receive agent)
- MRI incompatible (i.e. implant, metal, > 300 lbs, severe claustrophobia)
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
Neurocognitive Testing (PET/CT, MEG, fMRI w/ DTI)results
Time frame: 4 years
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 11 Dec 2015.
- St. Louis University Home Page for the Traumatic Brain Injury StudyLink provided by the sponsor.
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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.
Richard Bucholz, M.D. principal investigator
St. Louis University
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 and Post-Traumatic Stress Disorder, run by St. Louis University 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 4 inclusion and 4 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 11 Dec 2015. 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?
Neurocognitive Testing (PET/CT, MEG, fMRI w/ DTI)results (time frame: 4 years). 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 11 Dec 2015.