NCT01212029

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 159 (actual)
• Sponsor: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · NIH
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Accepted

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.

Conditions

• Cognition

Interventions

Type	Name	Description
BEHAVIORAL	Behavioral measures	Behavioral tasks/ questionnaires
DEVICE	fNIRS Devices & Application	Device 1- fNIRSoft and Device 2 - NIRScout
OTHER	Physiological measures	A set of tasks.

Timeline

• Start date: 2011-09-08
• Primary completion: 2024-02-21
• Completion: 2024-10-02
• First posted: 2010-09-30
• Last updated: 2025-04-17
• Results posted: 2025-04-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study