Testing and Calibration of Non-Invasive Optical Imaging Technology for Functional Brain Imaging



Status:Recruiting
Conditions:Neurology, Hematology
Therapuetic Areas:Hematology, Neurology
Healthy:No
Age Range:18 - Any
Updated:8/11/2018
Start Date:August 31, 2010
Contact:Emma E Condy
Email:emma.condy@nih.gov
Phone:(301) 402-7801

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Background:

- Non-invasive functional near infrared (fNIR) imaging techniques use infrared light to
detect changes in blood volume and oxygen levels during brain activity. fNIR is being studied
as a possible way to examine the brain activity of individuals who are unable to undergo
standard brain function imaging techniques (such as functional magnetic resonance imaging, or
fMRI). For instance, war veterans who have iron shrapnel in the body are not able to have
fMRI scans, and very young children or children with autism and related disorders are often
not able or willing to cooperate long enough in the MRI environment to allow full imaging
studies to take place. Researchers are interested in comparing the results of fNIR and fMRI
performed on healthy volunteers to determine if fNIR produces similarly accurate results.

Objectives:

- To examine the capabilities of non-invasive functional near infrared imaging techniques on
healthy volunteers and compare the results with the existing outcomes of functional magnetic
resonance imaging.

Eligibility:

- Healthy volunteers at least 18 years of age.

Design:

- Participants will have one study visit. Depending on the complexity of the task, the
whole exam will take between 5 minutes and 1 hour to perform.

- Participants will be asked to sit as still as possible while wearing a headband that
includes light sources and detectors (the fNIR device).

- Participants will be asked to perform a set of tasks (e.g., reading sentences or
counting numbers in one s head). Data will be collected during these experiments.

Objective: to cross-validate our near infrared spectroscopy (NIRS) imaging system with
existing functional magnetic resonance imaging (fMRI) data, and b) to investigate any
significant technical issues associated with optode placement and motion artifacts, and to
explore techniques that will potentially improve the feasibility and reliability of the
system according to the needs of the population whom existing imaging systems are unsuitable
for.

Study population: 150 healthy volunteers

Design: The study will look for correlations between NIRS signal changes in healthy subjects
when performing functional tasks, and existing fMRI data.

Outcome Measures: graded changes in blood flow and oxygen, measured with NIRS, in response to
different functional tasks.

Note: This study is sponsored by the Center for Neuroscience and Regenerative Medicine
(CNRM). De-identified data including imaging data sent to CNRM may be shared with outside
investigators or collaborators. This data may be used for a variety of research purposes. The
Henry M. Jackson Foundation for the Advancement for Military Medicine (HJF), USUHS, or DoD
representatives may also access data for audit purposes.

- INCLUSION CRITERIA:

Age 18 years or greater.

EXCLUSION CRITERIA:

- Healthy volunteers with any skin disease.

- Past or present hematologic abnormality of Hgb less than 9.0 gm/dl.

- Healthy volunteers with any past or present vascular disease

- Known adverse reaction to latex.

- Any medical condition that, in the opinion of the Principal Investigator, would
preclude the inclusion of a patient onto this research study.

- Unable or unwilling to give informed consent.
We found this trial at
1
site
9000 Rockville Pike
Bethesda, Maryland 20892
Phone: 800-411-1222
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from
Bethesda, MD
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