Traumatic Brain InjuryDana-REACNCT01298557
MEG and DTI of Neural Function and Connectivity in Traumatic Brain Injury
An observational study of Traumatic Brain Injury and Post-concussive Symptoms, run by University of California, San Francisco at 1 site in United States.
Trial summary
The overall hypothesis is that the long-term cognitive and behavioral sequelae of traumatic brain injury (TBI) are due to selective disruption of the long association white matter tracts of the cerebral hemispheres, with resulting functional impairment of the network of cortical regions that are interconnected by… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Traumatic Brain Injury, Post-concussive Symptoms
- How many people
- 69 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Feb 2013
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Participants will be recruited through the neurosurgery clinic at San Francisco General Hospital or referred to us by colleagues.
Who may be able to join
- 18-50 years of age
- single episode of blunt traumatic brain injury
- symptoms of persistent post-concussive syndrome present an average of 4 months to 4 years since date of injury
- fluency in English (cognitive battery not available in other languages)
- capable of self-consent
Who cannot join
- < 18 years or > 50 years of age
- pregnancy
- history of previous TBI with loss of consciousness
- alcoholism as evidenced by Audit questionnaire
- regular use of illicit drugs
- non-English fluency
- significant psychiatric history excluding mild depression or anxiety disorder any contraindication to MRI, including claustrophobia, pregnancy, any trauma or surgery which may have left ferromagnetic material in the body, ferromagnetic implants or pacemakers; and inability to lie still for 1 hour or more
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco General Hospital
San Francisco, California, 94110
About this study
Official title: Magnetoencephalography and High-Field Diffusion Tensor Magnetic Resonance Imaging of Neural Function and Connectivity in Traumatic Brain Injury
The overall hypothesis is that the long-term cognitive and behavioral sequelae of traumatic brain injury (TBI) are due to selective disruption of the long association white matter tracts of the cerebral hemispheres, with resulting functional impairment of the network of cortical regions that are interconnected by these long-range association pathways. We propose that traumatic white matter injury can be measured with diffusion tensor imaging (DTI) and that the impaired cortical activation can be detected with magnetoencephalography (MEG), and that the results of these imaging examinations will correlate with neurocognitive status and functional recovery after TBI.
- Conditions
- Traumatic Brain Injury, Post-concussive Symptoms
- Keywords
- Traumatic brain injury, Post-concussive symptoms, Brain imaging, Neurocognitive testing
- Medical subject headings
- Brain Injuries, Traumatic, Post-Concussion Syndrome
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 |
|---|---|---|
| Traumatic brain injured patients | This group consists of participants who suffered a traumatic brain injury an average of 4 months to 4 years prior to testing. Patients must not have history of prior head injury, substance abuse, psychiatric illness, or contraindications to MRI. | |
| Controls (no traumatic brain injury) | This group consists of participants who do not have a history of brain trauma. Furthermore, controls must not suffer from substance abuse, psychiatric illness, or have contraindications to the MRI. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in white matter tract structure
We believe that brain injury results in selective disruption of the associative white matter tracts of the cerebral hemispheres, with resulting functional impairment of the network of cortical regions that are interconnected by these long-range association pathways. We propose that traumatic white matter injury can be measured with diffusion tensor imaging (DTI). We evaluate DTI using 3T and 7T MRI. Participants receive scans at only one time-point.
Measured: up to 4 years following date of injury
Secondary outcomes (2)
Neurocognitive function
We hope to better understand the long-term cognitive and behavioral sequelae of traumatic brain injury (TBI) by correlating neurocognitive testing data with imaging data. We will also compare neurocognitive testing data between patients and controls to help illustrate the impact of brain trauma on these neurocognitive symptoms. Our participants receive testing at only one time-point.
Measured: up to 4 years following date of injury
Cortical activation
We believe that brain injury results in selective disruption of the associative white matter tracts of the cerebral hemispheres, with resulting functional impairment of the network of cortical regions that are interconnected by these long-range association pathways. We propose that impaired cortical activation can be detected with magnetoencephalography (MEG). We will compare patients' data with data of controls. Our participants are scanned at only one time-point.
Measured: up to 4 years following date of injury
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2011 (estimated)
- Study startFeb 2007
- Primary completionFeb 2013
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Time perspective
- Prospective
- Enrolment
- 69 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pratik Mukherjee, MD, PhD, Principal investigator, UCSF Department of Radiology and Bioengineering
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01298557
- Sponsor's protocol ID
- Dana-REAC
- Acronym
- Dana-REAC
- Status last verified
- Nov 2018
- First submitted
- 9 Feb 2011
- Last updated
- 4 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Arfanakis K, Haughton VM, Carew JD, Rogers BP, Dempsey RJ, Meyerand ME. Diffusion tensor MR imaging in diffuse axonal injury. AJNR Am J Neuroradiol. 2002 May;23(5):794-802.
PubMed 12006280Deipolyi AR, Mukherjee P, Gill K, Henry RG, Partridge SC, Veeraraghavan S, Jin H, Lu Y, Miller SP, Ferriero DM, Vigneron DB, Barkovich AJ. Comparing microstructural and macrostructural development of the cerebral cortex in premature newborns: diffusion tensor imaging versus cortical gyration. Neuroimage. 2005 Sep;27(3):579-86. doi: 10.1016/j.neuroimage.2005.04.027.
PubMed 15921934Hillebrand A, Singh KD, Holliday IE, Furlong PL, Barnes GR. A new approach to neuroimaging with magnetoencephalography. Hum Brain Mapp. 2005 Jun;25(2):199-211. doi: 10.1002/hbm.20102.
PubMed 15846771Hughes DG, Jackson A, Mason DL, Berry E, Hollis S, Yates DW. Abnormalities on magnetic resonance imaging seen acutely following mild traumatic brain injury: correlation with neuropsychological tests and delayed recovery. Neuroradiology. 2004 Jul;46(7):550-8. doi: 10.1007/s00234-004-1227-x. Epub 2004 Jun 8.
PubMed 15185054Huisman TA, Sorensen AG, Hergan K, Gonzalez RG, Schaefer PW. Diffusion-weighted imaging for the evaluation of diffuse axonal injury in closed head injury. J Comput Assist Tomogr. 2003 Jan-Feb;27(1):5-11. doi: 10.1097/00004728-200301000-00002.
PubMed 12544235
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetoencephalography and High-Field Diffusion Tensor Magnetic Resonance Imaging of Neural Function and Connectivity in Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT01298557
- Acronym / sponsor ID
- Dana-REAC / Dana-REAC
- Conditions
- Traumatic Brain Injury, Post-concussive Symptoms
- Keywords
- Traumatic brain injury, Post-concussive symptoms, Brain imaging, Neurocognitive testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 69 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Feb 2013 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 17 Feb 2011 (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 overall hypothesis is that the long-term cognitive and behavioral sequelae of traumatic brain injury (TBI) are due to selective disruption of the long association white matter tracts of the cerebral hemispheres, with resulting functional impairment of the network of cortical regions that are interconnected by these long-range association pathways. We propose that traumatic white matter injury can be measured with diffusion tensor imaging (DTI) and that the impaired cortical activation can be detected with magnetoencephalography (MEG), and that the results of these imaging examinations will correlate with neurocognitive status and functional recovery after TBI.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Traumatic brain injured patients | – | –This group consists of participants who suffered a traumatic brain injury an average of 4 months to 4 years prior to testing. Patients must not have history of prior head injury, substance abuse, psychiatric illness, or contraindications to MRI. |
| Controls (no traumatic brain injury) | – | –This group consists of participants who do not have a history of brain trauma. Furthermore, controls must not suffer from substance abuse, psychiatric illness, or have contraindications to the MRI. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Participants will be recruited through the neurosurgery clinic at San Francisco General Hospital or referred to us by colleagues.
Key inclusion criteria (5 listed)
- 18-50 years of age
- single episode of blunt traumatic brain injury
- symptoms of persistent post-concussive syndrome present an average of 4 months to 4 years since date of injury
- fluency in English (cognitive battery not available in other languages)
- capable of self-consent
Key exclusion criteria (7 listed)
- < 18 years or > 50 years of age
- pregnancy
- history of previous TBI with loss of consciousness
- alcoholism as evidenced by Audit questionnaire
- regular use of illicit drugs
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
Changes in white matter tract structure
Time frame: up to 4 years following date of injury
We believe that brain injury results in selective disruption of the associative white matter tracts of the cerebral hemispheres, with resulting functional impairment of the network of cortical regions that are interconnected by these long-range association pathways. We propose that traumatic white matter injury can be measured with diffusion tensor imaging (DTI). We evaluate DTI using 3T and 7T MRI. Participants receive scans at only one time-point.
2 secondary outcomes
Neurocognitive function
Time frame: up to 4 years following date of injury
Cortical activation
Time frame: up to 4 years following date of 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 4 Dec 2018.
- Background: PubMed 12006280Arfanakis K, Haughton VM, Carew JD, Rogers BP, Dempsey RJ, Meyerand ME. Diffusion tensor MR imaging in diffuse axonal injury. AJNR Am J Neuroradiol. 2002 May;23(5):794-802.
- Background: PubMed 15921934Deipolyi AR, Mukherjee P, Gill K, Henry RG, Partridge SC, Veeraraghavan S, Jin H, Lu Y, Miller SP, Ferriero DM, Vigneron DB, Barkovich AJ. Comparing microstructural and macrostructural development of the cerebral cortex in premature newborns: diffusion tensor imaging versus cortical gyration. Neuroimage. 2005 Sep;27(3):579-86. doi: 10.1016/j.neuroimage.2005.04.027.
- Background: PubMed 15846771Hillebrand A, Singh KD, Holliday IE, Furlong PL, Barnes GR. A new approach to neuroimaging with magnetoencephalography. Hum Brain Mapp. 2005 Jun;25(2):199-211. doi: 10.1002/hbm.20102.
- Background: PubMed 15185054Hughes DG, Jackson A, Mason DL, Berry E, Hollis S, Yates DW. Abnormalities on magnetic resonance imaging seen acutely following mild traumatic brain injury: correlation with neuropsychological tests and delayed recovery. Neuroradiology. 2004 Jul;46(7):550-8. doi: 10.1007/s00234-004-1227-x. Epub 2004 Jun 8.
- Background: PubMed 12544235Huisman TA, Sorensen AG, Hergan K, Gonzalez RG, Schaefer PW. Diffusion-weighted imaging for the evaluation of diffuse axonal injury in closed head injury. J Comput Assist Tomogr. 2003 Jan-Feb;27(1):5-11. doi: 10.1097/00004728-200301000-00002.
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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.
Pratik Mukherjee, MD, PhD principal investigator
UCSF Department of Radiology and Bioengineering
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-concussive Symptoms, run by University of California, San Francisco 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 5 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: finished, as of the sponsor's last update on 4 Dec 2018. 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?
Changes in white matter tract structure (time frame: up to 4 years following date of injury). 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 NCT01298557, which also lists 5 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 4 Dec 2018.