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

Cognition Clinical Trial

Official title:

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

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT01212029
• Other study ID #: 100198
• Secondary ID: 10-CH-0198
• Status: Suspended
• Phase: N/A
• Start date: September 8, 2011
• Est. completion date: March 31, 2025

Study information

• Verified date: June 18, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Suspended
• Enrollment: 126
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Cognition

Intervention

Behavioral:
• Behavioral measures
Behavioral tasks/ questionnaires

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

Other:
• Physiological measures
A set of tasks.

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (5)

Lead Sponsor	Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	Center for Neuroscience and Regenerative Medicine (CNRM), National Institute on Deafness and Other Communication Disorders (NIDCD), National Institutes of Health Clinical Center (CC), United States Department of Defense

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validate NIRFI imaging data results with fMRI data	Validate NIRFI imaging data results with fMRI data and assess the uses of NIRS techniques as a developing neuroimaging modality	End of Study
Primary	Collect functional optical imaging data	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	Assess any significant issues associated with NIRS optode placement	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
Secondary	Assess neurovascular changes	Assess neurovascular changes, including blood volume and blood oxygenation fluctuations, during functional events and validate observed changes with published literature	End of study

External Links

•   NIH Clinical Center Detailed Web Page