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

NCT01212029 | Completed Results FDA Device

• 2 other identifiers: 10019810-CH-0198
• Study Type: interventional
• Target: 159
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognition

Keywords

fNIRS; Healthy Volunteer; HV

Outcome Measures

Primary Outcomes (2)

• Relationship Between Prefrontal Cortex Activation and Respiratory Sinus Arrhythmia

  Prefrontal cortex (PFC) activation is measured in term of change in oxyhemoglobin (O2Hb) using a functional Near-Infrared Spectroscopy (fNIRS) system at a person forehead. Respiratory Sinus Arrhythmia (RSA) is the variation of heart beat in response to breathing. It is calculated as changes in the lengths of interbeat interval as a result of breathing using root mean square successive difference (RMSSD). The relationship between activation of PFC and RSA is quantified as a linear regression coefficient, which represents the estimated average change in O2Hb concentration associated with a 1 unit increase in RMSSD in heartrate interbeat interval length.

  During the assessment

• Mean Change in Oxyhemoblobin Concentration in Left Dorsolateral Prefrontal Cortex Region After Impersonal Moral Judgement Dilemma

  Moral judgment (MJ) is the process of evaluating what is right or wrong based on social norms. The classic Trolley Dilemma describes an impersonal MJ scenario in which a trolley is hurtling toward five workers on the track. One option presented is to flip a switch to divert the course of the trolley, which would result in the trolley hurtling toward one person on the opposite side of the track, killing this one person. The other is to do nothing and allow the five workers to die. Dorsolateral prefrontal cortex (DL-PFC) is responsible for utilitarian (logical) judgments that are thought to engage more cognitive processes and fewer emotional processes. Oxyhemoglobin (O2Hb) is measured using a functional Near-Infrared Spectroscopy (fNIRS) at prefrontal cortex.

  During the assessment

Secondary Outcomes (2)

• Number of Participants With Significant Issues Associated With NIRS

  During the assessment

• Number of Participants With High Performance But Low Prefrontal Cortex Activation

  During the assessment

Study Arms (1)

1/All Subjects

EXPERIMENTAL

Imaging studies related to functional brain activation

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

Interventions

Behavioral measures BEHAVIORAL

Behavioral tasks/ questionnaires

1/All Subjects

fNIRS Devices & Application DEVICE

Device 1- fNIRSoft and Device 2 - NIRScout

1/All Subjects

Physiological measures OTHER

A set of tasks.

1/All Subjects

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or greater.

You may not qualify if:

• 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.
• Unable or unwilling to give informed consent.

Sponsors & Collaborators

• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): lead
• Center for Neuroscience and Regenerative Medicine (CNRM): collaborator
• United States Department of Defense: collaborator
• National Institutes of Health Clinical Center (CC): collaborator
• National Institute on Deafness and Other Communication Disorders (NIDCD): collaborator

Study Sites (1)

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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.

  PMID: 15035670 BACKGROUND

• 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.

  PMID: 1985272 BACKGROUND

• 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.

  PMID: 9347608 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

Results Point of Contact

• Title: Dr. Amir Gandjbakhche
• Organization: National Institute of Child Health and Human Development

gandjbaa@mail.nih.gov

2402742949

Study Officials

• Amir Gandjbakhche, Ph.D.

  Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2010
• First Posted: September 30, 2010
• Study Start: September 8, 2011
• Primary Completion: February 21, 2024
• Study Completion: October 2, 2024
• Last Updated: April 17, 2025
• Results First Posted: April 17, 2025

Record last verified: 2024-10-02

Locations

US (1)