Recruiting

tPBM

Sponsor:

University of Oklahoma

Code:

NCT07209683

Conditions

Cognition

Neurovascular Coupling Mechanism and Cognitive Function

Neurovascular Control

Brain Aging

Brain Activity

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

Interventions

transcranial photobiomodulation

Study Details

Brief 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

Study ID

NCT07209683

Start date

Oct 1, 2025

Status verified date

Feb, 2026

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Sep 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21 - 70+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

Interventions

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Peter Mukli, MD, PhD

+1 (405) 271-8001peter-mukli@ou.edu

Norbert S Dosa, MD

+1 (405) 271-8130norbert-dosa@ou.edu

Locations

University of Oklahoma Health Campus

Recruiting

Oklahoma City, Oklahoma, United States, 73104

Contacts

Peter Mukli Mukli, MD PhD

405-271-8001peter-mukli@ou.edu

OUHSC Director, Office of H. R. P. P.

405-271-2045

Principal Investigator:

Peter Mukli, MD PhD

More Information

Sponsor

University of Oklahoma

Last update posted

Feb 6, 2026

Last verified

Feb, 2026

Keywords

  • transcranial photobiomodulation
  • neurovascular coupling
  • aging
  • cognitive function
  • near-infrared spectroscopy
  • electroencephalography
  • dynamic vessel analysis
  • home-based intervention
  • randomized double-blinded clinical trial

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Oklahoma on 2026-02-06.