NCT07759648

Brief Summary

The investigators aimed to investigate the effects of different cognitive load tasks (1-back, 2-back, 3-back) on low-frequency oscillations (LFOs) in the prefrontal cortex of healthy young individuals, analyze the relationship between LFO parameters (power, peak amplitude, peak frequency) and behavioral performance (reaction time, accuracy), and validate the feasibility of using LFOs as a quantitative measure of brain resting-state activity and a sensitive indicator of cognitive load.Low-frequency oscillations (LFO, 0.05-0.15 Hz) are a core feature of cerebral hemodynamics and are closely related to neural activity, blood pressure regulation, and metabolic function. Existing studies suggest that LFO may be influenced by cognitive load during mental tasks, but the underlying mechanisms remain unclear. Functional near-infrared spectroscopy (fNIRS), with its advantages of non-invasiveness, portability, and high temporal resolution, enables precise monitoring of hemodynamic parameters in the prefrontal cortex, including changes in oxygenated and deoxygenated hemoglobin concentrations (Δ\[oxy-Hb\], Δ\[deoxy-Hb\]). This study combines the N-back working memory task to investigate how cognitive load modulates LFO, offering a novel approach for assessing brain function.In this study, the investigators used a portable 16-channel continuous-wave functional near-infrared spectroscopy (fNIRS) system to measure dynamic changes in prefrontal cortex (PFC) hemodynamic parameters-Δ\[oxy-Hb\], Δ\[deoxy-Hb\], and Δ\[tot-Hb\]-in 48 healthy participants under varying task loads. The investigators then analyzed low-frequency oscillations (LFOs) based on the detected hemodynamic parameter fluctuations, following established methodologies from prior research. Using Welch's method, LFOs were extracted from power spectral density (PSD) of different hemodynamic parameters across three task conditions (1-back, 2-back, and 3-back). The principle of fNIRS relies on near-infrared light penetrating the skull and brain, being absorbed by chromophores \[HbO₂\] and \[Hb\] with distinct absorption spectra. Assuming constant scattering and applying the modified Beer-Lambert law during calculations, sensitive light intensity detectors can detect concentration changes of these chromophores within the subject's brain tissue. The experimental setup consisted of a 4.4 cm × 15 cm sensor array distributed across the forehead, a dedicated data acquisition control box with a sampling rate of 3.3 Hz, and a computer for data storage and analysis software. The current flexible sensor comprises four light sources and ten detectors. The light sources include three built-in LEDs with peak wavelengths at 735 nm, 805 nm, and 850 nm, while the detectors are designed to image the sub-frontal cortical regions (dorsolateral and ventromedial prefrontal cortices). The distance between each source and its surrounding detectors is 2.89 cm, enabling hemodynamic measurements at depths of 2-3 cm beneath the scalp, focusing primarily on the cerebral cortex. Each light source is arranged in an X-shape with four adjacent detectors, where the source is centered and detectors positioned at the corners, forming channels connecting each source to individual detectors. The prefrontal cortex is a region strongly associated with cognitive processing and plays a critical role in working memory tasks. Task load was implemented through working memory tasks-a mechanism by which the brain temporarily processes and stores information crucial for handling complex cognitive demands. Understanding how the amplitude of hemodynamic oscillations is modulated by different cognitive loads is significant, as microvascular blood flow is regulated by myogenic mechanisms. These foundational insights will help improve the analysis and interpretation of hemodynamic neuroimaging data. This study employs fNIRS, a non-invasive neuroimaging technique highly sensitive to microvascular activity, to investigate the interactive effects of cognitive load on brain hemodynamic LFOs.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

June 24, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 12, 2026

Completed
Last Updated

August 12, 2026

Status Verified

August 1, 2026

Enrollment Period

1 month

First QC Date

June 24, 2026

Last Update Submit

August 6, 2026

Conditions

Keywords

Low frequency oscillationsFunctional near-infrared spectroscopyWorking memoryPrefrontal cortex hemodynamicsTask-load effect

Outcome Measures

Primary Outcomes (3)

  • Peak Amplitude of Low-Frequency Oscillations (LFO) Measured by functional Near-Infrared Spectroscopy (fNIRS)

    1. The peak amplitude of LFO (0.05-0.15 Hz) will be extracted from the power spectral density (PSD) of the relative changes in oxygenated and deoxygenated hemoglobin concentrations in the prefrontal cortex. This is measured using a 16-channel portable continuous-wave fNIRS system during different cognitive load tasks (1-back, 2-back, and 3-back). 2. Measurement Tool: 16-channel continuous-wave fNIRS system. 3. Unit of Measure: Perived from relative hemoglobin concentration changes and after log-transformed-power spectral density (PSD) in certain frequency :lg(μM\^2/Hz).

    Day1, The assessment time point was after the n-back task, with spectral analysis performed on low-frequency oscillation data collected during the 377-second n-back experiment.

  • Peak frequency of Low-Frequency Oscillations (LFO) Measured by fNIRS

    1. The frequency at which the maximum power occurs within the low-frequency band (0.05-0.15 Hz) derived from the PSD of prefrontal cortex hemoglobin concentration changes. This assesses the shift in vascular oscillation frequency under varying cognitive loads (1-back, 2-back, 3-back). 2. Measurement Tool: 16-channel continuous-wave fNIRS system. 3. Unit of Measure: Hertz (Hz).

    Day1, The assessment time point was after the n-back task, with spectral analysis performed on low-frequency oscillation data collected during the 377-second n-back experiment.

  • Power of Low-Frequency Oscillations (LFO) Measured by fNIRS

    1. The total signal power within the low-frequency band (0.05-0.15 Hz) calculated from the PSD of hemoglobin concentration changes during the working memory tasks. The power spectral data undergoes a logarithmic transformation prior to statistical analysis to ensure normal distribution. 2. Measurement Tool: 16-channel continuous-wave fNIRS system. 3. Unit of Measure: derived from relative hemoglobin concentration changes after log-transformed: lg(μM\^2)

    Day1, The assessment time point was after the n-back task, with spectral analysis performed on low-frequency oscillation data collected during the 377-second n-back experiment.

Secondary Outcomes (3)

  • Reaction Time Assessed by N-back Behavioral Task System

    Day1, The assessment time point was after the n-back task, analyzing behavioral reaction times during the 377-second n-back experiment.

  • Accuracy Rate Assessed by N-back Behavioral Task System

    Day 1, the assessment time point was after the n-back task, analyzing behavioral accuracy rate during the 377-second n-back experiment.

  • Correlation Between LFO Parameters and Task Behavioral Performance

    Day 1, the assessment time point was after the n-back task, analyzing behavioral correlation between low frequency oscillation parameters and task behavioral performance during the 377-second n-back experiment.

Study Arms (1)

No category

Device: N-back Visual working memory task

Interventions

The investigators employed the N-back visual working memory task, a continuous letter task with varying working memory load demands. The task consisted of four fixation blocks and three task blocks, lasting a total of 377 seconds. Each fixation block lasted 20 seconds, during which participants were instructed to fixate their gaze on a central point. The working memory load gradually increased from 1-back to 3-back across the task blocks. Participants were required to determine whether the current letter matched the previous letter (1-back), the letter two positions back (2-back), or the letter three positions back (3-back) in terms of features, responding with one button for "yes" and another for "no."

No category

Eligibility Criteria

Age18 Years - 23 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

47 right-handed volunteers (23 males and 24 females) were recruited. Their ages ranged from 18 to 23 years, with an average age of 22.1 years for males and 21.5 years for females. The participants were young adults, as the study aimed to investigate the effects of LFO on cognitive activation, which involved a relatively challenging 3-back working memory task. All participants had normal or corrected-to-normal vision. Female participants were excluded if they were within their menstrual cycle, as hormonal fluctuations during this period may affect certain prefrontal cortical functions. None of the participants had a history of neurological or psychiatric disorders, nor were they taking any psychotropic medications. Participants abstained from alcohol, caffeine, and nicotine for at least 24 hours prior to the experiment.

You may qualify if:

  • Aged 18 to 23 years
  • Right-hand
  • Normal or corrected-to-normal vision
  • Willing to abstain from alcohol, caffeine, and nicotine for at least 24 hours prior to the experiment
  • Able to understand the study procedures and provide written informed consent

You may not qualify if:

  • History of neurological or psychiatric disorders (e.g., epilepsy, severe insomnia, or anxiety)
  • History of arrhythmia or other severe cardiovascular conditions
  • Current or long-term use of psychotropic medications or other medications affecting the nervous system
  • Contraindications for wearing skin-mounted optical devices
  • Female participants currently in their menstrual cycle (due to potential hormonal effects on prefrontal cortical functions)
  • Inability to follow experimental instructions or complete the testing tasks

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

16 channel fNIRS

Tianjin, Tianjin Municipality, 300192, China

Location

Related Publications (1)

  • [1] Biswal B, Zerrin Yetkin F, Haughton V M, et al. Functional connectivity in the motor cortex of resting human brain using echo-planar MRI[J]. Magnetic resonance in medicine, 1995, 34(4): 537-541. [2] Tong Y, Hocke L M, Licata S C, et al. Low-frequency oscillations measured in the periphery with near-infrared spectroscopy are strongly correlated with blood oxygen level-dependent functional magnetic resonance imaging signals[J]. Journal of biomedical optics, 2012, 17(10): 106004-106004. [3] Auer D P. Spontaneous low-frequency blood oxygenation level-dependent fluctuations and functional connectivity analysis of the 'resting'brain[J]. Magnetic resonance imaging, 2008, 26(7): 1055-1064. [4] Morita Y, Hardebo J E, Bouskela E. Influence of cerebrovascular sympathetic, parasympathetic, and sensory nerves on autoregulation and spontaneous vasomotion[J]. Acta physiologica scandinavica, 1995, 154(2): 121-130 [5] Vern B A, Schuette W H, Leheta B, et al. Low-frequency oscillations of cortical oxidative metabolism in waking and sleep[J]. Journal of Cerebral Blood Flow & Metabolism, 1988, 8(2): 215-226. [6] Lin PY, Roche-Labarbe N, Dehaes M, Carp S, Fenoglio A, Barbieri B, Hagan K, Grant PE, Franceschini MA. Non-invasive optical measurement of cerebral metabolism and hemodynamics in infants. J Vis Exp. 2013 Mar 14;(73):e4379. [7] Diehl R R, Linden D, Lücke D, et al. Spontaneous blood pressure oscillations and cerebral autoregulation[J]. Clinical Autonomic Research, 1998, 8(1): 7-12. [8] Katura T, Tanaka N, Obata A, et al. Quantitative evaluation of interrelations between spontaneous low-frequency oscillations in cerebral hemodynamics and systemic cardiovascular dynamics[J]. Neuroimage, 2006, 31(4): 1592-1600. [9] Cui X, Bray S, Bryant DM, Glover GH, Reiss AL. A quantitative comparison of NIRS and fMRI across multiple cognitive tasks. Neuroimage. 2011 Feb 14;54(4):2808-21. [10] Biswal B B, Kylen J V, Hyde J S. Simultaneous assessment of flow and BOLD signals in resting-state fu

    RESULT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 24, 2026

First Posted

August 12, 2026

Study Start

June 1, 2025

Primary Completion

July 1, 2025

Study Completion

October 1, 2025

Last Updated

August 12, 2026

Record last verified: 2026-08

Data Sharing

IPD Sharing
Will not share

Protection of personal information and privacy of participants

Locations