N/A
N=159
Testing and Calibration of Non-Invasive Optical Imaging Technology for Functional Brain Imaging
Cognition
Bottom Line
View on ClinicalTrials.gov: NCT01212029 ↗Enrolled (actual)
159
Serious AEs
0.0%
Results posted
Apr 2025
Primary outcome: Primary: Relationship Between Prefrontal Cortex Activation and Respiratory Sinus Arrhythmia — -0.064; 0.00375 Micro mol per second — p=0.008
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Behavioral measures (Behavioral); fNIRS Devices & Application (Device); Physiological measures (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Primary completion
- Feb 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Relationship Between Prefrontal Cortex Activation and Respiratory Sinus Arrhythmia |
-0.064; 0.00375 | 0.008 sig |
| PRIMARY Mean Change in Oxyhemoblobin Concentration in Left Dorsolateral Prefrontal Cortex Region After Impersonal Moral Judgement Dilemma |
0.0784 | 0.0105 sig |
| SECONDARY Number of Participants With Significant Issues Associated With NIRS |
6 | — |
| SECONDARY Number of Participants With High Performance But Low Prefrontal Cortex Activation |
18 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01212029). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.