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

NCT01212029 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2025-04-17

Study results available
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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

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.

Sponsors & Collaborators

  • Center for Neuroscience and Regenerative Medicine (CNRM)

    collaborator FED
  • United States Department of Defense

    collaborator FED
  • National Institutes of Health Clinical Center (CC)

    collaborator NIH
  • National Institute on Deafness and Other Communication Disorders (NIDCD)

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

    lead NIH

Principal Investigators

  • Amir Gandjbakhche, Ph.D. · Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Study Design

Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-09-08
Primary Completion
2024-02-21
Completion
2024-10-02
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01212029 on ClinicalTrials.gov