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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: March 31, 2024

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.

Interventions

  • Behavioral: Behavioral measures
    • Behavioral tasks/ questionnaires
  • Device: fNIRS Devices & Application
    • Device 1- fNIRSoft and Device 2 – NIRScout
  • Other: Physiological measures
    • A set of tasks.

Arms, Groups and Cohorts

  • Experimental: 1/All Subjects
    • Imaging studies related to functional brain activation

Clinical Trial Outcome Measures

Primary Measures

  • Validate NIRFI imaging data results with fMRI data
    • Time Frame: End of Study
    • Validate NIRFI imaging data results with fMRI data and assess the uses of NIRS techniques as a developing neuroimaging modality
  • Collect functional optical imaging data
    • Time Frame: End of Study
    • Collect functional optical imaging data from healthy volunteers, study patterns of near-surface cortical activation during performance of known tasks, and validate results with published literature

Secondary Measures

  • Assess any significant issues associated with NIRS optode placement
    • Time Frame: End of study
    • Assess any significant issues associated with NIRS optode placement and evaluate the effect of subject motion on data collection, quality, and noise
  • Assess neurovascular changes
    • Time Frame: End of study
    • Assess neurovascular changes, including blood volume and blood oxygenation fluctuations, during functional events and validate observed changes with published literature

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 99 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Collaborator
    • Center for Neuroscience and Regenerative Medicine (CNRM)
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Amir Gandjbakhche, Ph.D., Principal Investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Overall Contact(s)
    • Thein Nguyen, (301) 451-6649, thien.nguyen4@nih.gov

References

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.

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.

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.

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.