fMRI and NIRS Imaging for Traumatic Brain Injury



Status:Recruiting
Conditions:Cognitive Studies, Neurology
Therapuetic Areas:Neurology, Psychiatry / Psychology
Healthy:No
Age Range:18 - 60
Updated:5/27/2013
Start Date:July 2012
Contact:Franck Amyot, Ph.D.
Email:amyotf@mail.nih.gov
Phone:(301) 801-2082

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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.

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.


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.

- INCLUSION CRITERIA:

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

EXCLUSION CRITERIA:

- 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.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
301-496-4000
National Institutes of Health Clinical Center The National Institutes of Health (NIH) Clinical Center in...
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mi
from
Bethesda, MD
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