- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01212029
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed 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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Thein Nguyen
- Phone Number: (301) 451-6649
- Email: thien.nguyen4@nih.gov
Study Contact Backup
- Name: Amir Gandjbakhche, Ph.D.
- Phone Number: (301) 435-9235
- Email: amir@helix.nih.gov
Study Locations
-
-
Maryland
-
Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 1/All Subjects
Imaging studies related to functional brain activation
|
Behavioral tasks/ questionnaires
Device 1- fNIRSoft and Device 2 - NIRScout
A set of tasks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 a developing neuroimaging modality
|
End of Study
|
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
|
End of Study
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
End of study
|
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
|
End of study
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Amir Gandjbakhche, Ph.D., Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Publications and helpful links
General Publications
- Bozkurt A, Onaral B. Safety assessment of near infrared light emitting diodes for diffuse optical measurements. Biomed Eng Online. 2004 Mar 22;3(1):9. doi: 10.1186/1475-925X-3-9.
- Friedland RP, Iadecola C. Roy and Sherrington (1890): a centennial reexamination of "On the regulation of the blood-supply of the brain". Neurology. 1991 Jan;41(1):10-4. doi: 10.1212/wnl.41.1.10. No abstract available.
- Villringer A, Chance B. Non-invasive optical spectroscopy and imaging of human brain function. Trends Neurosci. 1997 Oct;20(10):435-42. doi: 10.1016/s0166-2236(97)01132-6.
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 100198
- 10-CH-0198
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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