CognitionNCT01212029
Testing and Calibration of Non-Invasive Optical Imaging Technology for Functional Brain Imaging
A study testing Behavioral measures, fNIRS Devices & Application and Physiological measures in people with Cognition, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognition
- What is being tested?
- Behavioral measures, fNIRS Devices & Application and Physiological measures
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 159 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Sep 2011to 2 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18 years or greater.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Cognition
- Being tested
- Behavioral measures, fNIRS Devices & Application, Physiological measures
- Keywords
- fNIRS, Healthy Volunteer, HV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral measuresBehavioural
Behavioral tasks/ questionnaires
fNIRS Devices & ApplicationDevice
Device 1- fNIRSoft and Device 2 - NIRScout
Physiological measuresOther
A set of tasks.
| Study group | Role | What they receive |
|---|---|---|
| 1/All Subjects | Experimental | Imaging studies related to functional brain activation Receives: Behavioral: Behavioral measures; Device: fNIRS Devices & Application; Other: Physiological measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: During the assessment
Secondary outcomes (2)
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.
Measured: During the assessment
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.
Measured: During the assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2010 (estimated)
- Study start8 Sep 2011
- Primary completion21 Feb 2024
- Study completion2 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CognitionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Collaborators
- 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)
- Responsible party
- Sponsor
- Investigators
- Amir Gandjbakhche, Ph.D., Principal investigator, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01212029
- Sponsor's protocol ID
- 100198
- Other IDs
- 10-CH-0198
- Status last verified
- 2 Oct 2024
- First submitted
- 29 Sep 2010
- Last updated
- 17 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
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.
PubMed 15035670Friedland 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.
PubMed 1985272Villringer 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.
PubMed 9347608
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing and Calibration of Non-Invasive Optical Imaging Technology for Functional Brain Imaging
- ClinicalTrials.gov ID
- NCT01212029
- Acronym / sponsor ID
- 100198
- Conditions
- Cognition
- Keywords
- fNIRS, Healthy Volunteer, HV
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Collaborators
- 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)
- Study start
- 8 Sep 2011 (actual)
- Primary completion
- 21 Feb 2024 (actual)
- Study completion
- 2 Oct 2024 (actual)
- First posted
- 30 Sep 2010 (estimated)
- Results
- Posted 17 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1/All Subjects | Experimental | Behavioral: Behavioral measures, Device: fNIRS Devices & Application, Other: Physiological measuresImaging studies related to functional brain activation |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18 years or greater.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Behavioral measuresBehavioral tasks/ questionnaires | Behavioural | 1/All Subjects |
| fNIRS Devices & ApplicationDevice 1- fNIRSoft and Device 2 - NIRScout | Device | 1/All Subjects |
| Physiological measuresA set of tasks. | Other | 1/All Subjects |
Primary outcome
Relationship Between Prefrontal Cortex Activation and Respiratory Sinus Arrhythmia
Time frame: 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
Time frame: 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.
2 secondary outcomes
Number of Participants With Significant Issues Associated With NIRS
Time frame: During the assessment
Number of Participants With High Performance But Low Prefrontal Cortex Activation
Time frame: During the assessment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15035670Bozkurt 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.
- Background: PubMed 1985272Friedland 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.
- Background: PubMed 9347608Villringer 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amir Gandjbakhche, Ph.D. principal investigator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral measures, fNIRS Devices & Application and Physiological measures in people with Cognition, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 17 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship Between Prefrontal Cortex Activation and Respiratory Sinus Arrhythmia (time frame: During the assessment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01212029, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2025.