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

United States Department of Health and Human Services (HHS)

Status: Completed

Conditions: Cognition

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

Study type: Interventional

Funder types: Other U.S. Federal agency; NIH

Identifiers

NCT01212029

100198

10-CH-0198

Details and patient eligibility

About

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.

Full 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.

Enrollment: 159 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

159 participants in 1 patient group

1/All Subjects

Experimental group

Description:

Imaging studies related to functional brain activation

Treatment:

Other: Physiological measures

Device: fNIRS Devices & Application

Behavioral: Behavioral measures