Trial Outcomes & Findings for Testing and Calibration of Non-Invasive Optical Imaging Technology for Functional Brain Imaging (NCT NCT01212029)

NCT ID: NCT01212029

Last Updated: 2025-04-17

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

159 participants

Primary outcome timeframe

During the assessment

Results posted on

2025-04-17

Participant Flow

Participant milestones

Participant milestones
Measure	1/All Subjects Imaging studies related to functional brain activation
Overall Study STARTED	159
Overall Study COMPLETED	159
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

6 participants did not report their gender.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Subjects n=159 Participants Imaging studies related to functional brain activation
Age, Continuous	36 year STANDARD_DEVIATION 13 • n=159 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=159 Participants
Race (NIH/OMB) Asian	27 Participants n=159 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=159 Participants
Race (NIH/OMB) Black or African American	30 Participants n=159 Participants
Race (NIH/OMB) White	77 Participants n=159 Participants
Race (NIH/OMB) More than one race	3 Participants n=159 Participants
Race (NIH/OMB) Unknown or Not Reported	21 Participants n=159 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	15 Participants n=159 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	128 Participants n=159 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	16 Participants n=159 Participants
Sex: Female, Male Female	87 Participants n=153 Participants • 6 participants did not report their gender.
Sex: Female, Male Male	66 Participants n=153 Participants • 6 participants did not report their gender.

PRIMARY outcome

Timeframe: During the assessment

Population: Healthy adults (mean age = 37.18 years, SD = 14.67).

Outcome measures

Outcome measures
Measure	Baseline n=38 Participants Relationship between PFC activation and RSA was evaluated during baseline condition, where participants were instructed to sit quietly while watching a mildly stimulating video presented on a computer monitor. Data reported is the mean and standard deviation of the regression coefficients of RMSSD predicting O2Hb during baseline across all 16 fNIRS channels at the prefrontal cortex.	Go/No-Go Task n=38 Participants Relationship between PFC activation and RSA was evaluated during a Go/No-Go task. During the task, participants were instructed to press the space bar in a keyboard when they saw the letter "Y" and not to press any buttons when they saw the letter "X" displayed in a monitor. Data reported is the mean and standard deviation of the regression coefficients of RMSSD predicting O2Hb during Go/No-Go task across all 16 fNIRS channels at the prefrontal cortex.
Relationship Between Prefrontal Cortex Activation and Respiratory Sinus Arrhythmia	-0.064 Micro mol per second Standard Deviation 0.035	0.00375 Micro mol per second Standard Deviation 0.023

PRIMARY outcome

Timeframe: During the assessment

Population: Healthy participants (15 male, 18 female), aged 18-58 years, with a mean age of 33.7 years.

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.

Outcome measures

Outcome measures
Measure	Baseline n=33 Participants Relationship between PFC activation and RSA was evaluated during baseline condition, where participants were instructed to sit quietly while watching a mildly stimulating video presented on a computer monitor. Data reported is the mean and standard deviation of the regression coefficients of RMSSD predicting O2Hb during baseline across all 16 fNIRS channels at the prefrontal cortex.	Go/No-Go Task Relationship between PFC activation and RSA was evaluated during a Go/No-Go task. During the task, participants were instructed to press the space bar in a keyboard when they saw the letter "Y" and not to press any buttons when they saw the letter "X" displayed in a monitor. Data reported is the mean and standard deviation of the regression coefficients of RMSSD predicting O2Hb during Go/No-Go task across all 16 fNIRS channels at the prefrontal cortex.
Mean Change in Oxyhemoblobin Concentration in Left Dorsolateral Prefrontal Cortex Region After Impersonal Moral Judgement Dilemma	0.0784 Micro mol Standard Deviation 0.0102	—

SECONDARY outcome

Timeframe: During the assessment

Population: Healthy adults

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.

Outcome measures

Outcome measures
Measure	Baseline n=44 Participants Relationship between PFC activation and RSA was evaluated during baseline condition, where participants were instructed to sit quietly while watching a mildly stimulating video presented on a computer monitor. Data reported is the mean and standard deviation of the regression coefficients of RMSSD predicting O2Hb during baseline across all 16 fNIRS channels at the prefrontal cortex.	Go/No-Go Task Relationship between PFC activation and RSA was evaluated during a Go/No-Go task. During the task, participants were instructed to press the space bar in a keyboard when they saw the letter "Y" and not to press any buttons when they saw the letter "X" displayed in a monitor. Data reported is the mean and standard deviation of the regression coefficients of RMSSD predicting O2Hb during Go/No-Go task across all 16 fNIRS channels at the prefrontal cortex.
Number of Participants With Significant Issues Associated With NIRS	6 participants	—

SECONDARY outcome

Timeframe: During the assessment

Population: Healthy adults (15 female, 14 male) aged 20-59 years (mean age = 36.2, SD= 12.35).

High performance group include people with accuracy score greater than 90% during an n-back task.

Outcome measures

Outcome measures
Measure	Baseline n=29 Participants Relationship between PFC activation and RSA was evaluated during baseline condition, where participants were instructed to sit quietly while watching a mildly stimulating video presented on a computer monitor. Data reported is the mean and standard deviation of the regression coefficients of RMSSD predicting O2Hb during baseline across all 16 fNIRS channels at the prefrontal cortex.	Go/No-Go Task Relationship between PFC activation and RSA was evaluated during a Go/No-Go task. During the task, participants were instructed to press the space bar in a keyboard when they saw the letter "Y" and not to press any buttons when they saw the letter "X" displayed in a monitor. Data reported is the mean and standard deviation of the regression coefficients of RMSSD predicting O2Hb during Go/No-Go task across all 16 fNIRS channels at the prefrontal cortex.
Number of Participants With High Performance But Low Prefrontal Cortex Activation	18 Participants	—

Adverse Events

Neural Effects of Acute Physical Activity on Posture and Inhibitory Control Dual Task

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Neural Effects of Acute Physical Activity on Posture and Inhibitory Control Dual Task n=159 participants at risk This study investigates neural mechanisms underlying posture-inhibitory control dual-tasking and the acute effects of physical activity on dual-task performance.
General disorders Hypertension using CTCAE	1.9% 3/159 • Number of events 3 • 1 hour

Additional Information

Dr. Amir Gandjbakhche

National Institute of Child Health and Human Development

Phone: 2402742949

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place