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Protocol Details

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

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

10-CH-0198

Sponsoring Institute

National Institute of Child Health and Human Development (NICHD)

Recruitment Detail

Type: Completed Study; data analyses ongoing
Gender: Male & Female
Min Age: 18 Years
Max Age: 99 Years

Referral Letter Required

Yes

Population Exclusion(s)

Children

Keywords

fNIRS

Recruitment Keyword(s)

Healthy Volunteer;
HV

Condition(s)

Cognition

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

Behavioral: Behavioral measures
Device: fNIRS Devices & Application
Other: Physiological measures

Supporting Site

National Institute of Child Health and Human DevelopmentCenter for Neuroscience and Regenerative Medicine (CNRM)Department of DefenseNIH Clinical CenterNational Institute on Deafness and Other Communication Disorders

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.

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Eligibility

INCLUSION CRITERIA:

Age 18 years or greater.

EXCLUSION CRITERIA:

-Healthy volunteers with any skin disease that, in the opinion of the investigator, would interfere with the study measurements.

-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.


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Citations:

Bozkurt A, Onaral B. Safety assessment of near infrared light emitting diodes for diffuse optical measurements. Biomed Eng Online. 2004 Mar 22;3(1):9.

Friedland RP, Iadecola C. Roy and Sherrington (1890): a centennial reexamination of "On the regulation of the blood-supply of the brain". Neurology. 1991 Jan;41(1):10-4.

Villringer A, Chance B. Non-invasive optical spectroscopy and imaging of human brain function. Trends Neurosci. 1997 Oct;20(10):435-42.

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Contacts:

Principal Investigator

Referral Contact

For more information:

Amir Gandjbakhche, Ph.D.
National Institute of Child Health and Human Development (NICHD)
National Institutes of Health
Building 12A
Room 2003
12 South Drive
Bethesda, Maryland 20892
(301) 435-9235
gandjbaa@mail.nih.gov

Thien Nguyen
National Institute of Child Health and Human Development (NICHD)
National Institutes of Health
Building 49
Room 5A75
49 Convent Drive
Bethesda, Maryland 20892
(301) 451-6649
thien.nguyen4@nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1
ccopr@nih.gov

Clinical Trials Number:

NCT01212029

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