RecruitingNot ApplicableNCT07209683

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

Age-specific Neurovascular Effects of Transcranial Photobiomodulation


Sponsor

University of Oklahoma

Enrollment

30 participants

Start Date

Oct 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 21 YearsMax Age: 85 Years

Inclusion Criteria4

  • Age: 21-85 years of age
  • Adequate hearing and visual acuity to participate in the examinations
  • Ability to read and write in English
  • Competence to provide informed consent

Exclusion Criteria8

  • Active CNS disease including multiple sclerosis, uncontrolled seizures, active brain cancer
  • Cerebrovascular accident other than TIA within 60 days prior to Visit 0
  • Major psychiatric disease, including major depression not currently controlled on medications, alcohol or drug abuse
  • Participant currently uses commercial brain stimulation / neuromodulation device or an experimental device as part of a research study, e.g. tDCS, tACS, TBS, DBS, TMS, TPBM, etc.
  • Participant currently takes dietary supplements with an expected cerebrovascular benefit, such as NAD- or NR-supplement, L-citrulline, urolithin
  • Unstable medical condition, including uncontrolled diabetes, chronic heart issues, heart failure, chronic obstructive pulmonary disease, Stage 2 hypertension uncontrolled by medication (\>160/100 mmHg)
  • Any other medical condition or medication which, in the opinion of investigator, would render the patient inappropriate or too unstable to complete the study protocol.
  • Pregnancy or trying to become pregnant in the next 1 months (self-reported), breastfeeding

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Interventions

DEVICEtranscranial 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.


Locations(1)

University of Oklahoma Health Campus

Oklahoma City, Oklahoma, United States

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NCT07209683


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