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

This study is currently recruiting participants.
Verified June 8, 2017 by National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) )
Sponsor:
ClinicalTrials.gov Identifier:
NCT01212029
First Posted: September 30, 2010
Last Update Posted: July 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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) )
  Purpose

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
Neurovascular Coupling Hemoglobin Functional Brain Imaging

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Testing and Calibration of Non-Invasive Optical Imaging Technology for Functional Brain Imaging

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) ):

Estimated Enrollment: 100
Study Start Date: August 25, 2010
Detailed Description:

Objective: to cross-validate our near infrared spectroscopy (NIRS) imaging system with existing functional magnetic resonance imaging (fMRI) 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 for.

Study population: 100 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.

Note: This study is sponsored by the Center for Neuroscience and Regenerative Medicine (CNRM). De-identified data including imaging data sent to CNRM may be shared with outside investigators or collaborators. This data may be used for a variety of research purposes. The Henry M. Jackson Foundation for the Advancement for Military Medicine (HJF), USUHS, or DoD representatives may also access data for audit purposes.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  • Past or present hematologic abnormality of Hgb less than 9.0 gm/dl.
  • 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
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
Contact: Fatima A Chowdhry (301) 402-7804 fatima.chowdhry@nih.gov
Contact: Amir Gandjbakhche, Ph.D. (301) 435-9235 amir@helix.nih.gov

Locations
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 Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.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
Principal Investigator: Amir Gandjbakhche, Ph.D. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  More Information

Additional Information:
Publications:
Responsible Party: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT01212029     History of Changes
Other Study ID Numbers: 100198
10-CH-0198
First Submitted: September 29, 2010
First Posted: September 30, 2010
Last Update Posted: July 21, 2017
Last Verified: June 8, 2017

Keywords provided by National Institutes of Health Clinical Center (CC) ( Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) ):
Near Infrared
Optical Imaging
Brain Imaging
Healthy Volunteer
HV


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