Trial record 1 of 1 for:    10-CH-0198
Previous Study | Return to List | Next Study

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

This study is currently recruiting participants.
Verified March 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Collaborators:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT01212029
First received: September 29, 2010
Last updated: April 15, 2014
Last verified: March 2013

September 29, 2010
April 15, 2014
August 2010
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT01212029 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Testing and Calibration of Non-Invasive Optical Imaging Technology for Functional Brain Imaging
Testing and Calibration of Non-Invasive Optical Imaging Technology for Functional Brain Imaging

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.

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: 40 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.

Observational
Time Perspective: Prospective
Not Provided
Not Provided
Not Provided
Not Provided
  • Neurovascular Coupling
  • Hemoglobin
  • Functional Brain Imaging
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
40
Not Provided
Not Provided
  • 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.
Both
18 Years and older
Yes
Contact: Fatima A Chowdhry (301) 402-7804 fatima.chowdhry@nih.gov
Contact: Amir Gandjbakhche, Ph.D. (301) 435-9235 amir@helix.nih.gov
United States
 
NCT01212029
100198, 10-CH-0198
Not Provided
Not Provided
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • Center for Neuroscience and Regenerative Medicine (CNRM)
  • Department of Defense
  • National Institutes of Health Clinical Center (CC)
Principal Investigator: Amir Gandjbakhche, Ph.D. Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
National Institutes of Health Clinical Center (CC)
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP