Clinical trial NCT01212029: Testing and Calibration of Non-Invasive Optical Imaging Technology for Functional Brain Imaging
Official title: Testing and Calibration of Non-Invasive Optical Imaging Technology for Functional Brain Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognition
Keywords: fNIRS
Healthy Volunteer
HV
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
Collaborators: name: Center for Neuroscience and Regenerative Medicine (CNRM)
name: United States Department of Defense
name: National Institutes of Health Clinical Center (CC)
name: National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted: 2010-09-30
Enrollment: 159
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: Objective: to a) cross-validate our near infrared spectroscopy (NIRS) imaging system with existing functional magnetic resonance imaging (fMRI) and electroencephalogram (EEG) 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 for whom existing imaging systems are unsuitable.

Study population: 250 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.

Eligibility criteria: * 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.

Primary outcomes:
measure: Relationship Between Prefrontal Cortex Activation and Respiratory Sinus Arrhythmia
timeFrame: During the assessment
measure: Mean Change in Oxyhemoblobin Concentration in Left Dorsolateral Prefrontal Cortex Region After Impersonal Moral Judgement Dilemma
timeFrame: During the assessment
Secondary outcomes:
measure: Number of Participants With Significant Issues Associated With NIRS
timeFrame: During the assessment
measure: Number of Participants With High Performance But Low Prefrontal Cortex Activation
timeFrame: During the assessment
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
name: Amir Gandjbakhche, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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. doi: 10.1186/1475-925X-3-9.
citation: 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. doi: 10.1212/wnl.41.1.10. No abstract available.
citation: Villringer A, Chance B. Non-invasive optical spectroscopy and imaging of human brain function. Trends Neurosci. 1997 Oct;20(10):435-42. doi: 10.1016/s0166-2236(97)01132-6.