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| ID | Type | Description | Link |
|---|---|---|---|
| 10-CH-0198 |
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| Name | Class |
|---|---|
| Center for Neuroscience and Regenerative Medicine (CNRM) | FED |
| United States Department of Defense | FED |
| National Institutes of Health Clinical Center (CC) | NIH |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1/All Subjects | Experimental | Imaging studies related to functional brain activation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Behavioral measures | Behavioral | Behavioral tasks/ questionnaires |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Relationship Between Prefrontal Cortex Activation and Respiratory Sinus Arrhythmia | Prefrontal cortex (PFC) activation is measured in term of change in oxyhemoglobin (O2Hb) using a functional Near-Infrared Spectroscopy (fNIRS) system at a person forehead. Respiratory Sinus Arrhythmia (RSA) is the variation of heart beat in response to breathing. It is calculated as changes in the lengths of interbeat interval as a result of breathing using root mean square successive difference (RMSSD). The relationship between activation of PFC and RSA is quantified as a linear regression coefficient, which represents the estimated average change in O2Hb concentration associated with a 1 unit increase in RMSSD in heartrate interbeat interval length. | During the assessment |
| Mean Change in Oxyhemoblobin Concentration in Left Dorsolateral Prefrontal Cortex Region After Impersonal Moral Judgement Dilemma | Moral judgment (MJ) is the process of evaluating what is right or wrong based on social norms. The classic Trolley Dilemma describes an impersonal MJ scenario in which a trolley is hurtling toward five workers on the track. One option presented is to flip a switch to divert the course of the trolley, which would result in the trolley hurtling toward one person on the opposite side of the track, killing this one person. The other is to do nothing and allow the five workers to die. Dorsolateral prefrontal cortex (DL-PFC) is responsible for utilitarian (logical) judgments that are thought to engage more cognitive processes and fewer emotional processes. Oxyhemoglobin (O2Hb) is measured using a functional Near-Infrared Spectroscopy (fNIRS) at prefrontal cortex. | During the assessment |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Significant Issues Associated With NIRS | Assess any significant issues associated with NIRS optode placement and evaluate the effect of subject motion on data collection, quality, and noise. Data from participants with significant issues, which either due to NIRS optode placement or subject motion, data quality, and noise, are removed from further analysis. | During the assessment |
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Age 18 years or greater.
EXCLUSION CRITERIA:
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| Name | Affiliation | Role |
|---|---|---|
| Amir Gandjbakhche, Ph.D. | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institutes of Health Clinical Center | Bethesda | Maryland | 20892 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15035670 | Background | 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. | |
| 1985272 | Background | 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. |
| Label | URL |
|---|---|
| NIH Clinical Center Detailed Web Page | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 1/All Subjects | Imaging studies related to functional brain activation |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 1, 2022 |
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| National Institute on Deafness and Other Communication Disorders (NIDCD) |
| NIH |
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| fNIRS Devices & Application |
| Device |
Device 1- fNIRSoft and Device 2 - NIRScout |
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| Physiological measures | Other | A set of tasks. |
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| Number of Participants With High Performance But Low Prefrontal Cortex Activation | High performance group include people with accuracy score greater than 90% during an n-back task. | During the assessment |
| 9347608 | Background | 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. |
| COMPLETED |
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| NOT COMPLETED |
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6 participants did not report their gender.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subjects | Imaging studies related to functional brain activation |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | year |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Sex: Female, Male | 6 participants did not report their gender. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Relationship Between Prefrontal Cortex Activation and Respiratory Sinus Arrhythmia | Prefrontal cortex (PFC) activation is measured in term of change in oxyhemoglobin (O2Hb) using a functional Near-Infrared Spectroscopy (fNIRS) system at a person forehead. Respiratory Sinus Arrhythmia (RSA) is the variation of heart beat in response to breathing. It is calculated as changes in the lengths of interbeat interval as a result of breathing using root mean square successive difference (RMSSD). The relationship between activation of PFC and RSA is quantified as a linear regression coefficient, which represents the estimated average change in O2Hb concentration associated with a 1 unit increase in RMSSD in heartrate interbeat interval length. | Healthy adults (mean age = 37.18 years, SD = 14.67). | Posted | Mean | Standard Deviation | Micro mol per second | During the assessment |
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| Primary | Mean Change in Oxyhemoblobin Concentration in Left Dorsolateral Prefrontal Cortex Region After Impersonal Moral Judgement Dilemma | Moral judgment (MJ) is the process of evaluating what is right or wrong based on social norms. The classic Trolley Dilemma describes an impersonal MJ scenario in which a trolley is hurtling toward five workers on the track. One option presented is to flip a switch to divert the course of the trolley, which would result in the trolley hurtling toward one person on the opposite side of the track, killing this one person. The other is to do nothing and allow the five workers to die. Dorsolateral prefrontal cortex (DL-PFC) is responsible for utilitarian (logical) judgments that are thought to engage more cognitive processes and fewer emotional processes. Oxyhemoglobin (O2Hb) is measured using a functional Near-Infrared Spectroscopy (fNIRS) at prefrontal cortex. | Healthy participants (15 male, 18 female), aged 18-58 years, with a mean age of 33.7 years. | Posted | Mean | Standard Deviation | Micro mol | During the assessment |
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| Secondary | Number of Participants With Significant Issues Associated With NIRS | Assess any significant issues associated with NIRS optode placement and evaluate the effect of subject motion on data collection, quality, and noise. Data from participants with significant issues, which either due to NIRS optode placement or subject motion, data quality, and noise, are removed from further analysis. | Healthy adults | Posted | Number | participants | During the assessment |
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| Secondary | Number of Participants With High Performance But Low Prefrontal Cortex Activation | High performance group include people with accuracy score greater than 90% during an n-back task. | Healthy adults (15 female, 14 male) aged 20-59 years (mean age = 36.2, SD= 12.35). | Posted | Count of Participants | Participants | During the assessment |
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1 hour
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Neural Effects of Acute Physical Activity on Posture and Inhibitory Control Dual Task | This study investigates neural mechanisms underlying posture-inhibitory control dual-tasking and the acute effects of physical activity on dual-task performance. | 0 | 159 | 0 | 159 | 3 | 159 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypertension using CTCAE | General disorders | Non-systematic Assessment | Increase of blood pressure in 3 participants after a 1 minute sit and stand task where a participant alternatively sit and stand continuously for 1 minute. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Amir Gandjbakhche | National Institute of Child Health and Human Development | 2402742949 | gandjbaa@mail.nih.gov |
| Feb 7, 2025 |
| Prot_SAP_000.pdf |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Unknown or Not Reported |
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| Male |
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| Participants |
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