Cognition
Conditions
Keywords
fNIRS, Healthy Volunteer, HV
Brief 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.
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.
Interventions
BEHAVIORALBehavioral measures
Behavioral tasks/ questionnaires
DEVICEfNIRS Devices & Application
Device 1- fNIRSoft and Device 2 - NIRScout
A set of tasks.
Sponsors
Center for Neuroscience and Regenerative Medicine (CNRM)
United States Department of Defense
National Institutes of Health Clinical Center (CC)
National Institute on Deafness and Other Communication Disorders (NIDCD)
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relationship Between Prefrontal Cortex Activation and Respiratory Sinus Arrhythmia | During the assessment | 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. |
| Mean Change in Oxyhemoblobin Concentration in Left Dorsolateral Prefrontal Cortex Region After Impersonal Moral Judgement Dilemma | During the assessment | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Significant Issues Associated With NIRS | During the assessment | 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. |
| Number of Participants With High Performance But Low Prefrontal Cortex Activation | During the assessment | High performance group include people with accuracy score greater than 90% during an n-back task. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Subjects Imaging studies related to functional brain activation | 159 |
| Total | 159 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Continuous | 36 year STANDARD_DEVIATION 13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 128 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 16 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 27 Participants |
| Race (NIH/OMB) Black or African American | 30 Participants |
| Race (NIH/OMB) More than one race | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 21 Participants |
| Race (NIH/OMB) White | 77 Participants |
| Sex: Female, Male Female | 87 Participants |
| Sex: Female, Male Male | 66 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 159 |
| other Total, other adverse events | 3 / 159 |
| serious Total, serious adverse events | 0 / 159 |
Outcome results
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.
Time frame: During the assessment
Population: Healthy participants (15 male, 18 female), aged 18-58 years, with a mean age of 33.7 years.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | Mean Change in Oxyhemoblobin Concentration in Left Dorsolateral Prefrontal Cortex Region After Impersonal Moral Judgement Dilemma | 0.0784 Micro mol | Standard Deviation 0.0102 |
p-value: 0.0105Tukey method
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.
Time frame: During the assessment
Population: Healthy adults (mean age = 37.18 years, SD = 14.67).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Baseline | Relationship Between Prefrontal Cortex Activation and Respiratory Sinus Arrhythmia | -0.064 Micro mol per second | Standard Deviation 0.035 |
| Go/No-Go Task | Relationship Between Prefrontal Cortex Activation and Respiratory Sinus Arrhythmia | 0.00375 Micro mol per second | Standard Deviation 0.023 |
Comparison: Null hypothesis: there is no significant correlation between RMSSD and O2Hb levels during baselinep-value: 0.008t-test, 2 sided
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.
Time frame: During the assessment
Population: Healthy adults (15 female, 14 male) aged 20-59 years (mean age = 36.2, SD= 12.35).
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Baseline | Number of Participants With High Performance But Low Prefrontal Cortex Activation | 18 Participants |
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.
Time frame: During the assessment
Population: Healthy adults
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Baseline | Number of Participants With Significant Issues Associated With NIRS | 6 participants |