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Healthy VolunteersNCT07759648

Non-invasive Optical Low-frequency Oscillation Study of the Prefrontal Cortex Based on fNIRS

An observational study of Healthy Volunteers and Working Memory Task, run by Peking Union Medical College at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 23 yearsHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers, Working Memory Task, Cognition
What is being tested?
N-back Visual working memory task
Type of treatment
Medical device
How many people
47 participants
Where
1 siteChina
Study dates
1 Jun 2025to 1 Oct 2025
Phase
Observational
Are there results?
None posted in the registry

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 23 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • 16 channel fNIRS

    Tianjin, Tianjin Municipality, 300192

Other trials in China

About this study

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.

Being tested
N-back Visual working memory task
Keywords
Low frequency oscillations, Functional near-infrared spectroscopy, Working memory, Prefrontal cortex hemodynamics, Task-load effect

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • N-back Visual working memory taskDevice

    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."

Study groups in NCT07759648
Study groupRoleWhat they receive
No categoryNot described
Receives: Device: N-back Visual working memory task

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 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.

  2. 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).

    Measured: 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.

  3. 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)

    Measured: 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)

  1. Reaction Time Assessed by N-back Behavioral Task System

    1. The average time participants take to make a judgment (via button press) on whether the currently displayed letter matches the target letter during the 1-back, 2-back, and 3-back working memory task blocks.
    2. Measurement Tool: Computerized N-back visual working memory task software.

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

  2. Accuracy Rate Assessed by N-back Behavioral Task System

    1. The percentage of correct button press responses made by the participant across the 30 randomly presented letters within each N-back task block (1-back, 2-back, 3-back).
    2. Measurement Tool: Computerized N-back visual working memory task software.
    3. Unit of Measure: Percentage (%).

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

  3. Correlation Between LFO Parameters and Task Behavioral Performance

    1. The statistical correlation evaluating the relationship between the fNIRS-derived LFO parameters (peak amplitude, peak frequency, log-transformed power) and the behavioral performance metrics (reaction time and accuracy) across different cognitive loads. This directly evaluates the feasibility of using LFO as a quantitative indicator of cognitive load.
    2. Measurement Tool: Statistical correlation analysis (e.g., Pearson or Spearman correlation coefficient).
    3. Unit of Measure: Correlation coefficient (r-value)

    Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2026
  2. Study start1 Jun 2025
  3. Primary completion1 Jul 2025
  4. Study completion1 Oct 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Other
Time perspective
Prospective
Enrolment
47 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07759648
Sponsor's protocol ID
2025(I)-203-01
Status last verified
Aug 2026
First submitted
24 Jun 2026
Last updated
12 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Protection of personal information and privacy of participants

Publications

  • [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

Questions about this trial

What is this clinical trial studying?

An observational study of Healthy Volunteers and Working Memory Task, run by Peking Union Medical College at 1 site in China.

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 5 inclusion and 6 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 12 Aug 2026. 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 China. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Peak Amplitude of Low-Frequency Oscillations (LFO) Measured by functional Near-Infrared Spectroscopy (fNIRS) (time frame: 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.). The study lists 3 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 NCT07759648, which also lists 1 linked publication.

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 12 Aug 2026.

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