Cognition DisorderNCT01668758
fMRI and NIRS Imaging for Traumatic Brain Injury
An observational study of Cognition Disorder and Functional Brain Imaging, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
Trial summary
Background: The amount of blood flowing in brain areas goes up when those areas are being used for activities, such as movement or seeing. Functional magnetic resonance imaging (fMRI) is a common way of measuring blood flow in the brain. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognition Disorder, Functional Brain Imaging
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 25 Jul 2012to 1 Jul 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy population
- Age 18 to 60, inclusive.
- Traumatic brain injuries population
- Age 18 to 60.
- Have a recorded past traumatic brain injuries rated in the Glasgow Coma Scale between 9 and 15
Who cannot join
- Pregnancy
- History of hypertension
- History of any disease of the central nervous system
- Current use of sedating medication, including antihistamines
- Subjects with any of the following will be excluded from MRI testing: aneurysm clip; implanted neural stimulator; implanted cardiac pacemaker or autodefibrillator; cochlear implant; ocular foreign body, such as metal shavings; permanent eyeliner; insulin pump; or irremovable body piercing due to the possible dangerous effects of the MRI magnet upon metal objects in the body.
About this study
Official title: Detection of Hemodynamic Changes in Traumatic Brain Injuries Population With Functional Near Infrared Spectroscopy
Background:
- The amount of blood flowing in brain areas goes up when those areas are being used for activities, such as movement or seeing. Functional magnetic resonance imaging (fMRI) is a common way of measuring blood flow in the brain. Near infrared spectroscopy (NIRS) can also be used to study blood flow in the brain. However, NIRS has not been used as often as fMRI. Researchers want to compare fMRI and NIRS to see whether they give similar results. These studies will be used to look at people who have had a traumatic brain injury.
Read more
Objectives:
- To test how well NIRS measure changes in blood flow in the brain after a traumatic brain injury.
Eligibility:
- Individuals between 18 and 60 years of age who have had a traumatic brain injury.
- Healthy volunteers at least 18 years of age.
Design:
- Participants will be screened with a physical exam and medical history. Researchers may ask to see brain images during from previous MRI scans.
- Participants will have a NIRS scan of the brain. They will be asked to do certain tasks while inside the scanner. These tasks will involve responding to images that appear on a screen.
- Treatment will not be provided as part of this study.
Read the detailed description
The goal of this study is to be able to assess frontal lobe function in a rapid, objective, and standardized way, without the need for expertise in cognitive test administration. Such methods would be particularly helpful in mild traumatic brain injury, where objective measures are needed, and would greatly expand the capacity to make such assessments in standard clinical practice.
Our goal is to recruit 100 subjects total in two groups of age, gender, and education matched subjects, as follows: TBI (n = 50) and non-TBI (n = 50).
The subject will be asked to perform 2 computer-based cognitive tests while the fNIRS device is in place. The fNIRS sensor pads will record changes in blood oxy/deoxy hemoglobin concentrations in the underlying cortex. Data will be stored for post processing analysis.
The main outcome measures will be: 1) a correlation of the fNIRS results between the TBI and non-TBI groups; 2) a correlation of the fNIRS results with the severity of the TBI within the TBI group. Finally, we plan to compare individual measurement from TBI patients with the healthy group.
- Conditions
- Cognition Disorder, Functional Brain Imaging
- Keywords
- Near Infrared Spectroscopy, Traumatic Brain Injury
- Medical subject headings
- Cognition Disorders, Brain Injuries, Traumatic
What is being measured
The primary outcome is the main question the study is designed to answer.
The main outcome measures will be to identify if the brain flow hemodynamic between the healthy and the TBI group is affected by trauma.
Secondary outcomes (1)
The secondary outcome of the two parametric paradigms will investigate if the degree of disruption correlates with measures of the severity of injury (GC scale). Finally, we will compare individual measurement form TBI patient with the health...
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2012 (estimated)
- Study start25 Jul 2012
- Study completion1 Jul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cognition DisorderStudies 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
- Time perspective
- Other
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Amir Gandjbakhche, Ph.D., Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01668758
- Sponsor's protocol ID
- 120165
- Other IDs
- 12-CH-0165
- Status last verified
- 1 Jul 2013
- First submitted
- 16 Aug 2012
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Hanna-Pladdy B. Dysexecutive syndromes in neurologic disease. J Neurol Phys Ther. 2007 Sep;31(3):119-27. doi: 10.1097/NPT.0b013e31814a63c2.
PubMed 18025957Maas AI, Stocchetti N, Bullock R. Moderate and severe traumatic brain injury in adults. Lancet Neurol. 2008 Aug;7(8):728-41. doi: 10.1016/S1474-4422(08)70164-9.
PubMed 18635021Strangman GE, Goldstein R, O'Neil-Pirozzi TM, Kelkar K, Supelana C, Burke D, Katz DI, Rauch SL, Savage CR, Glenn MB. Neurophysiological alterations during strategy-based verbal learning in traumatic brain injury. Neurorehabil Neural Repair. 2009 Mar-Apr;23(3):226-36. doi: 10.1177/1545968308324225. Epub 2008 Dec 1.
PubMed 19047359
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Hemodynamic Changes in Traumatic Brain Injuries Population With Functional Near Infrared Spectroscopy
- ClinicalTrials.gov ID
- NCT01668758
- Acronym / sponsor ID
- 120165
- Conditions
- Cognition Disorder, Functional Brain Imaging
- Keywords
- Near Infrared Spectroscopy, Traumatic Brain Injury
- Study type
- Observational
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- 25 Jul 2012
- Study completion
- 1 Jul 2013
- First posted
- 20 Aug 2012 (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.
Background:
- The amount of blood flowing in brain areas goes up when those areas are being used for activities, such as movement or seeing. Functional magnetic resonance imaging (fMRI) is a common way of measuring blood flow in the brain. Near infrared spectroscopy (NIRS) can also be used to study blood flow in the brain. However, NIRS has not been used as often as fMRI. Researchers want to compare fMRI and NIRS to see whether they give similar results. These studies will be used to look at people who have had a traumatic brain injury.
Objectives:
- To test how well NIRS measure changes in blood flow in the brain after a traumatic brain injury.
Eligibility:
- Individuals between 18 and 60 years of age who have had a traumatic brain injury.
- Healthy volunteers at least 18 years of age.
Design:
- Participants will be screened with a physical exam and medical history. Researchers may ask to see brain images during from previous MRI scans.
- Participants will have a NIRS scan of the brain. They will be asked to do certain tasks while inside the scanner. These tasks will involve responding to images that appear on a screen.
- Treatment will not be provided as part of this study.
Detailed description
The goal of this study is to be able to assess frontal lobe function in a rapid, objective, and standardized way, without the need for expertise in cognitive test administration. Such methods would be particularly helpful in mild traumatic brain injury, where objective measures are needed, and would greatly expand the capacity to make such assessments in standard clinical practice.
Our goal is to recruit 100 subjects total in two groups of age, gender, and education matched subjects, as follows: TBI (n = 50) and non-TBI (n = 50).
The subject will be asked to perform 2 computer-based cognitive tests while the fNIRS device is in place. The fNIRS sensor pads will record changes in blood oxy/deoxy hemoglobin concentrations in the underlying cortex. Data will be stored for post processing analysis.
The main outcome measures will be: 1) a correlation of the fNIRS results between the TBI and non-TBI groups; 2) a correlation of the fNIRS results with the severity of the TBI within the TBI group. Finally, we plan to compare individual measurement from TBI patients with the healthy group.
Study design
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy population
- Age 18 to 60, inclusive.
- Traumatic brain injuries population
- Age 18 to 60.
- Have a recorded past traumatic brain injuries rated in the Glasgow Coma Scale between 9 and 15
Key exclusion criteria (5 listed)
- Pregnancy
- History of hypertension
- History of any disease of the central nervous system
- Current use of sedating medication, including antihistamines
- Subjects with any of the following will be excluded from MRI testing: aneurysm clip; implanted neural stimulator; implanted cardiac pacemaker or autodefibrillator; cochlear implant; ocular foreign body, such as metal shavings; permanent eyeliner; insulin pump; or irremovable body piercing due to the possible dangerous effects of the MRI magnet upon metal objects in the body.
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
The main outcome measures will be to identify if the brain flow hemodynamic between the healthy and the TBI group is affected by trauma.
1 secondary outcome
The secondary outcome of the two parametric paradigms will investigate if the degree of disruption correlates with measures of the severity of injury (GC scale). Finally, we will compare individual measurement form TBI patient with the health...
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 2 Jul 2017.
- Background: PubMed 18025957Hanna-Pladdy B. Dysexecutive syndromes in neurologic disease. J Neurol Phys Ther. 2007 Sep;31(3):119-27. doi: 10.1097/NPT.0b013e31814a63c2.
- Background: PubMed 18635021Maas AI, Stocchetti N, Bullock R. Moderate and severe traumatic brain injury in adults. Lancet Neurol. 2008 Aug;7(8):728-41. doi: 10.1016/S1474-4422(08)70164-9.
- Background: PubMed 19047359Strangman GE, Goldstein R, O'Neil-Pirozzi TM, Kelkar K, Supelana C, Burke D, Katz DI, Rauch SL, Savage CR, Glenn MB. Neurophysiological alterations during strategy-based verbal learning in traumatic brain injury. Neurorehabil Neural Repair. 2009 Mar-Apr;23(3):226-36. doi: 10.1177/1545968308324225. Epub 2008 Dec 1.
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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.
Amir Gandjbakhche, Ph.D. principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Questions about this trial
What is this clinical trial studying?
An observational study of Cognition Disorder and Functional Brain Imaging, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD).
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 5 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 2 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The main outcome measures will be to identify if the brain flow hemodynamic between the healthy and the TBI group is affected by trauma.. 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 NCT01668758, which also lists 3 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 2 Jul 2017.