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

NCT07209683 | Recruiting FDA Device

• 1 other identifier: 18356
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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; Brain Aging; Neurovascular Coupling Mechanism and Cognitive Function; Neurovascular Control; Brain Activity

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Cognitive performance

  Cognitive performance will be assessed by using the following batteries of the NIH Toolbox: 1) Dimensional Change Card Sort \[executive function\]; 2) Pattern Comparison Processing Speed; 3) List Sorting Working Memory; 4) Flanker Inhibitory Control and Attention; 5) Picture Sequencing Memory and/or 6) Oral Symbol Digit Test.

  From baseline visit to the follow-up visit after completing a 4-week intervention protocol

Secondary Outcomes (4)

• Neurovascular coupling response

  From baseline visit to the follow-up visit after completing a 4-week intervention protocol

• Brain wave power

  From baseline visit to the follow-up visit after completing a 4-week intervention protocol

• Functional connectivity

  From baseline visit to the follow-up visit after completing a 4-week intervention protocol

• Retinal vasoreactivity

  From baseline visit to the follow-up visit after completing a 4-week intervention protocol

Other Outcomes (2)

• Cerebrovascular endothelium-derived extracellular vesicles

  From baseline visit to the follow-up visit after completing a 4-week intervention protocol

• Pro-inflammatory cytokines

  From baseline visit to the follow-up visit after completing a 4-week intervention protocol

Study Arms (2)

Active near-infrared light therapy

ACTIVE COMPARATOR

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.

Device: transcranial photobiomodulation

Sham near-infrared light therapy

SHAM COMPARATOR

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.

Device: transcranial photobiomodulation

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.

Also known as: near-infrared light therapy

Active near-infrared light therapy; Sham near-infrared light therapy

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oklahoma: lead

Study Sites (1)

University of Oklahoma Health Campus

Oklahoma City, Oklahoma, 73104, United States

RECRUITING

Related Publications (1)

• Chao LL. Effects of Home Photobiomodulation Treatments on Cognitive and Behavioral Function, Cerebral Perfusion, and Resting-State Functional Connectivity in Patients with Dementia: A Pilot Trial. Photobiomodul Photomed Laser Surg. 2019 Mar;37(3):133-141. doi: 10.1089/photob.2018.4555. Epub 2019 Feb 13.

  PMID: 31050950 BACKGROUND

Central Study Contacts

Peter Mukli, MD, PhD

CONTACT

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

Norbert S Dosa, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Unblinded and do not participate in outcome assessment and statistical analysis. These procedures are performed by blinded outcome assessors and blinded investigators.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is a randomized, parallel-group, double-blind, sham-controlled pilot trial. Healthy adult participants across multiple age groups (21-85 years) will be randomized in a 1:1 ratio to receive either active transcranial photobiomodulation (tPBM) or sham stimulation. Participants in both groups will complete 3-4 sessions per week for 4 weeks (20-minute sessions, every other day). Cognitive and physiological outcomes will be measured at baseline and post-intervention follow-up.

Study Record Dates

• First Submitted: September 26, 2025
• First Posted: October 7, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: February 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)