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 : September 17, 2019
- 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.
- 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.
- Healthy volunteers at least 18 years of age.
- 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|
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: 150 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.
|Study Type :||Observational|
|Estimated Enrollment :||150 participants|
|Official Title:||Testing and Calibration of Non-Invasive Optical Imaging Technology for Functional Brain Imaging|
|Actual Study Start Date :||September 8, 2011|
Healthy adults 18 years or older
- To find biological markers that will permit objective monitoring of response to therapy [ Time Frame: study completion ]Graded changes in blood flow and oxygen, measured with NIRS, in response to different tasks.
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
|Contact: Kosar Khaksari, Ph.D.||(301) firstname.lastname@example.org|
|Contact: Amir Gandjbakhche, Ph.D.||(301) email@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator:||Amir Gandjbakhche, Ph.D.||Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)|