Mild Traumatic Brain InjurymTBINCT01044615
Advanced Imaging Tools in the Study of Mild Traumatic Brain Injury
An observational study of Mild Traumatic Brain Injury, run by Kettering Health Network at 1 site in United States.
Trial summary
We will utilize a set of imaging modalities including computed tomography (CT), positron emission tomography (PET), and a suite of magnetic resonance imaging (MRI) tools, to investigate the changes in the human brain resulting from mild traumatic brain injury (mTBI). Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Mild Traumatic Brain Injury
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to not given
- 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 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Patients at Veteran's Administration Medical Center in Dayton, OH who have history of Mild Traumatic Brain Injury within 24 months prior to enrollment.
Who may be able to join
- Study group:
- Between 18 and 55 years of age inclusive.
- Potential participant verbally verifies diagnosis of mTBI at pre-screen.
- Diagnosed with mild traumatic brain injury by a VAMC physician according to standard diagnostic criteria [12],[13], to be verified by chart review.
- Less than 24 months from trauma resulting in mTBI.
- Able to read and write in English.
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- Willingness to refrain from nicotine, and beverages containing either alcohol or caffeine for at least four hours prior to the imaging session.
- Have signed the consent form for the study.
- Control Group:
- Between 18 and 55 years of age inclusive.
- Potential participant verbally denies history of mTBI at pre-screen.
- Able to read and write in English.
- Willingness to refrain from nicotine, and beverages containing either alcohol or caffeine for at least four hours prior to the imaging session.
- Have signed the consent form for the study
Who cannot join
- Conditions that would preclude the completion of a MRI, PET, or CT exam such as claustrophobia, pacemaker, metal objects in body, and/or pregnancy.
- Serious, unstable medical or mental illness.
- Medical contraindication to any element of the study procedure.
- Have not read and signed an informed consent form, or do not understand its contents.
Trial locations and contacts
1 site in 1 country.
About this study
We will utilize a set of imaging modalities including computed tomography (CT), positron emission tomography (PET), and a suite of magnetic resonance imaging (MRI) tools, to investigate the changes in the human brain resulting from mild traumatic brain injury (mTBI).
Read the detailed description
We will recruit mTBI subjects and control subjects. Each subject will undergo the set of imaging modalities, and the results will be analyzed for differences at the structural, physiological, and molecular levels. The long term goal of this research is the development of a method to diagnose mTBI based on physical markers. This is a phased project beginning with a pilot study followed by future studies with larger sample sizes.
- Conditions
- Mild Traumatic Brain Injury
- Keywords
- Mild Traumatic Brain Injury, Concussion, Magnetic Resonance Imaging (MRI), Positron Emission Tomography(PET), Computed Tomography (CT)
- Medical subject headings
- Brain Concussion
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 |
|---|---|---|
| Mild traumatic brain injury patients | Subjects who have a verifiable diagnosis of mild traumatic brain injury sustained within 24 months prior to enrollment | |
| Normal Control | Normal, healthy adults with no history of brain injury. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2010 (estimated)
- Study startDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kettering Health Network
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cincinnati
- Responsible party
- Sponsor
- Investigators
- Jason Parker, PhD, Principal investigator, Kettering Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01044615
- Sponsor's protocol ID
- mTBI
- Acronym
- mTBI
- Status last verified
- Jan 2013
- First submitted
- 6 Jan 2010
- Last updated
- 14 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Imaging Tools in the Study of Mild Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT01044615
- Acronym / sponsor ID
- mTBI / mTBI
- Conditions
- Mild Traumatic Brain Injury
- Keywords
- Mild Traumatic Brain Injury, Concussion, Magnetic Resonance Imaging (MRI), Positron Emission Tomography(PET), Computed Tomography (CT)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Kettering Health NetworkUniversity, hospital or other
- Collaborators
- University of Cincinnati
- Study start
- Dec 2010
- First posted
- 8 Jan 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.
We will utilize a set of imaging modalities including computed tomography (CT), positron emission tomography (PET), and a suite of magnetic resonance imaging (MRI) tools, to investigate the changes in the human brain resulting from mild traumatic brain injury (mTBI).
Detailed description
We will recruit mTBI subjects and control subjects. Each subject will undergo the set of imaging modalities, and the results will be analyzed for differences at the structural, physiological, and molecular levels. The long term goal of this research is the development of a method to diagnose mTBI based on physical markers. This is a phased project beginning with a pilot study followed by future studies with larger sample sizes.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mild traumatic brain injury patients | – | –Subjects who have a verifiable diagnosis of mild traumatic brain injury sustained within 24 months prior to enrollment |
| Normal Control | – | –Normal, healthy adults with no history of brain injury. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Patients at Veteran's Administration Medical Center in Dayton, OH who have history of Mild Traumatic Brain Injury within 24 months prior to enrollment.
Key inclusion criteria (14 listed)
- Between 18 and 55 years of age inclusive.
- Potential participant verbally verifies diagnosis of mTBI at pre-screen.
- Diagnosed with mild traumatic brain injury by a VAMC physician according to standard diagnostic criteria [12],[13], to be verified by chart review.
- Less than 24 months from trauma resulting in mTBI.
- Able to read and write in English.
Key exclusion criteria (4 listed)
- Conditions that would preclude the completion of a MRI, PET, or CT exam such as claustrophobia, pacemaker, metal objects in body, and/or pregnancy.
- Serious, unstable medical or mental illness.
- Medical contraindication to any element of the study procedure.
- Have not read and signed an informed consent form, or do not understand its contents.
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
Not reported in the source record.
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 14 Jan 2013.
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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.
Jason Parker, PhD principal investigator
Kettering Health Network
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 Mild Traumatic Brain Injury, run by Kettering Health Network 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 14 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 14 Jan 2013. 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.
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 14 Jan 2013.