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The Effect of Near-infrared Light Therapy on Brain Function and Cognition in Young and Older Adults

NCT07209683 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-02-06

No results posted yet for this study

Summary

The goal of this pilot clinical trial is to test whether transcranial photobiomodulation (tPBM), a non-invasive brain stimulation technique using near-infrared light, can improve brain blood flow regulation (neurovascular coupling) and cognitive function in older adults.

The main questions it aims to answer are:

* Does tPBM enhance neurovascular coupling responses during memory and finger tapping tasks?
* Are these improvements linked to better cognitive performance and lower levels of brain inflammation and oxidative stress?

Researchers will compare an active tPBM treatment arm to a sham treatment arm to see if tPBM leads to measurable improvements in brain activity and cognitive function compared to no active stimulation.

Participants will:

* Receive either active tPBM or sham stimulation sessions for 4 weeks, every other day using a portable intervention device.
* Complete questionnaires and an iPAD-based cognitive testing protocol
* Complete memory and motor tasks while their brain activity is measured using non-invasive techniques: simultaneous functional near-infrared spectroscopy (fNIRS) and electroencephalography (EEG), transcranial doppler (TCD) flowmetry.
* Retinal vessel reactivity will be measured during flickering light stimulus using a special camera (dynamic vessel analysis, DVA).
* Provide blood samples to test for biomarkers of inflammation, oxidative stress and brain cell damage.

Conditions

  • Cognition
  • Neurovascular Coupling Mechanism and Cognitive Function
  • Neurovascular Control
  • Brain Aging
  • Brain Activity

Interventions

DEVICE

transcranial photobiomodulation

The Vielight Neuro Gamma TPBM devices (©Vielight Inc.) will be used to transmit pulsed near-infrared (NIR) energy through the cranium. Device emits NIR photons at 810 m wavelength generating \~100 mW/cm2 pulsed NIR power modulated at 40 Hz frequency. The six NIR light sources are positioned along the midline over the frontal, pariatel and occipital cortices, bilaterally over the temporal cortex, and intranasally. Due to its portable design, Vielight Neuro TBPM instruments can be used in the laboratory, bedside, or at the participant's home. Active / sham photobiomodulation sessions last for 20 minutes and will be administered at a laboratory-, home-, or office-based setting depending on the preference of the participant. TPBM will be performed three or four times a week for four weeks, maximum once every other day. Participants will complete a questionnaire of adverse events after each photobiomodulation session.

Sponsors & Collaborators

  • University of Oklahoma

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-01
Primary Completion
2026-09-30
Completion
2026-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07209683 on ClinicalTrials.gov