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

Part of paid clinical trials in Oklahoma City, Oklahoma.

Sponsor
University of Oklahoma
Study ID
NCT07209683
Status
Recruiting
Apply to this trial

Conditions

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

Eligibility Criteria

Sex
ALL
Age
21 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • transcranial photobiomodulation — DEVICE
    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.

Study Details

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.

Key Dates

Start date
Oct 1, 2025
Status verified
Feb 2026
Primary completion
Sep 30, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Active near-infrared light therapy
    Participants in this arm will receive active transcranial photobiomodulation sessions every other day for 20 minutes during their participation in the study. The intervention will be administered by active Vielight Neuro Rx Gamma, a research version of a commercially available light therapy device categorized as a wellness product with non-significant risk. During these sessions, biologically effective near-infrared light will be administered.
  • Sham Comparator: Sham near-infrared light therapy
    Participants in this arm will receive sham transcranial photobiomodulation sessions every other day for 20 minutes during their participation in the study. The intervention will be administered by active Vielight Neuro Rx Gamma, a research version of a commercially available light therapy device categorized as a wellness product with non-significant risk. During these sessions, biologically effective near-infrared light will not be administered.

Primary Outcome Measure

Cognitive performance [ Time Frame: From baseline visit to the follow-up visit after completing a 4-week intervention protocol ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
University of Oklahoma Health CampusOklahoma CityOklahoma73104
Peter Mukli Mukli, MD PhD
[email protected]
405-271-8001
OUHSC Director, Office of H. R. P. P.
405-271-2045
Peter Mukli, MD PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Oklahoma City, OK

By research site
University of Oklahoma Health Campus· Oklahoma City, OK

Related Studies