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

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ClinicalTrials.gov Identifier: NCT01212029
Recruitment Status : Recruiting
First Posted : September 30, 2010
Last Update Posted : May 7, 2020
Sponsor:
Collaborators:
Center for Neuroscience and Regenerative Medicine (CNRM)
United States Department of Defense
National Institutes of Health Clinical Center (CC)
National Institute on Deafness and Other Communication Disorders (NIDCD)
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) )

Study Description
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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.

Condition or disease Intervention/treatment Phase
Cognition Behavioral: Behavioral measures Device: fNIRS Devices & Application Other: Physiological measures Not Applicable

Detailed Description:

Objective: to 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 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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Testing and Calibration of Non-Invasive Optical Imaging Technology for Functional Brain Imaging
Actual Study Start Date : September 8, 2011
Estimated Primary Completion Date : March 31, 2021
Estimated Study Completion Date : March 31, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: 1/All Subjects
Imaging studies related to functional brain activation
 Behavioral: Behavioral measures
Behavioral tasks/questionnaires

Device: fNIRS Devices & Application
Device 1- fNIRSoft and Device 2- NIRScout

Other: Physiological measures
A set of tasks


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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 developing neuroimaging modality


Secondary Outcome Measures :
  1. 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

  2. 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


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA:

Age 18 years or greater.

EXCLUSION CRITERIA:

  • Healthy volunteers with any skin disease.
  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01212029


Contacts
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Contact: Kosar Khaksari, Ph.D. (301) 496-6786 kosar.khaksari@nih.gov
Contact: Amir Gandjbakhche, Ph.D. (301) 435-9235 amir@helix.nih.gov

Locations
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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)    800-411-1222 ext TTY8664111010    prpl@cc.nih.gov   
Sponsors and Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Center for Neuroscience and Regenerative Medicine (CNRM)
United States Department of Defense
National Institutes of Health Clinical Center (CC)
National Institute on Deafness and Other Communication Disorders (NIDCD)
Investigators
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Principal Investigator: Amir Gandjbakhche, Ph.D. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
More Information
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Additional Information:

Publications:

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Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT01212029    
Other Study ID Numbers: 100198
10-CH-0198
First Posted: September 30, 2010    Key Record Dates
Last Update Posted: May 7, 2020
Last Verified: April 13, 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) ):
fNIRS
Healthy Volunteer
HV